Trial Outcomes & Findings for Extravascular ICD Pivotal Study (NCT NCT04060680)
NCT ID: NCT04060680
Last Updated: 2024-11-19
Results Overview
The primary safety endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 6 months (182 days) post-implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
393 participants
Primary outcome timeframe
6 Months (182 days) post implant
Results posted on
2024-11-19
Participant Flow
The first site was activated on 13SEP2019. The first EV ICD Pivotal subject was enrolled on 16SEP2019 and implanted on the same day. The last subject enrollment occurred on 14OCT2021, and the last implant occurred on 15OCT2021. Sites were notified of enrollment completion on 18OCT2021.
Among 356 enrolled subjects, 40 exited the study without having an implant attempt of the Extravascular ICD System due to: adverse event (2), physician decision (7), procedure not attempted (4), sponsor request (1), withdrawal by subject (10), and other reasons (16).
Participant milestones
| Measure |
Implant Attempt
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
Continued Access Implant Attempt
Continued Access
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
33
|
|
Overall Study
COMPLETED
|
292
|
31
|
|
Overall Study
NOT COMPLETED
|
24
|
2
|
Reasons for withdrawal
| Measure |
Implant Attempt
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
Continued Access Implant Attempt
Continued Access
|
|---|---|---|
|
Overall Study
Unsuccessful implant
|
17
|
2
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Study product no longer in use
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Extravascular ICD Pivotal Study
Baseline characteristics by cohort
| Measure |
Implant Attempt Pivotal
n=316 Participants
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
Implant Attempt Continued Access
n=33 Participants
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
49.2 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
53.4 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
199 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
197 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
New York Heart Association
Class I: No symptoms and no limitations in ordinary physical activity.
|
75 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
New York Heart Association
Class II: Slight limitation of physical activity.
|
184 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
New York Heart Association
Class III: Marked limitation of physical activity.
|
23 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
New York Heart Association
Class IV: Unable to carry on any physical activity without discomfort. Symptoms at rest.
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
New York Heart Association
Classification Not Available
|
34 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
New York Heart Association
No Heart Failure
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
ICD Indication
Primary Prevention
|
258 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
ICD Indication
Secondary Prevention
|
57 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
ICD Indication
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body Mass Index
|
28.0 kg/m^2
STANDARD_DEVIATION 5.6 • n=99 Participants
|
31 kg/m^2
STANDARD_DEVIATION 8 • n=107 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Region
Asia Pacific
|
37 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region
Europe, Middle East, and Africa
|
159 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Region
North America
|
120 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 Months (182 days) post implantPopulation: Subjects who underwent an implant attempt of the Extravascular ICD System
The primary safety endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 6 months (182 days) post-implant.
Outcome measures
| Measure |
Implant Attempt
n=316 Participants
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
|---|---|
|
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months Post-implant
|
293 Participants
|
PRIMARY outcome
Timeframe: At ImplantPopulation: Subjects who completed the implant defibrillation testing protocol
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
Outcome measures
| Measure |
Implant Attempt
n=302 Participants
Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD.
|
|---|---|
|
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
|
298 Participants
|
Adverse Events
Enrolled Pivotal
Serious events: 172 serious events
Other events: 20 other events
Deaths: 7 deaths
Enrolled Continued Access
Serious events: 6 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Enrolled Pivotal
n=356 participants at risk
Subjects enrolled in the Extravascular ICD Pivotal Study
|
Enrolled Continued Access
n=37 participants at risk
Subjects enrolled in the Extravascular ICD Continued Access Study (Used MedDRA 26.0)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
4/356 • Number of events 4 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Acute left ventricular failure
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Acute myocardial infection
|
1.1%
4/356 • Number of events 4 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Arrhythmic Storm
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
14/356 • Number of events 16 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Atrial flutter
|
0.84%
3/356 • Number of events 3 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
2.7%
1/37 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Bradycardia
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Bundle branch block left
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Bundle branch block right
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac failure
|
4.2%
15/356 • Number of events 18 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac failure acute
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac failure chronic
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
7/356 • Number of events 9 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Cardiogenic shock
|
0.84%
3/356 • Number of events 3 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Device inappropriate shock delivery
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Mitral valve incompetence
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Palpitations
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Pulseless electrical activity
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Sinus arrest
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Sinus tachycardia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.84%
3/356 • Number of events 3 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Ventricular fibrillation
|
2.2%
8/356 • Number of events 13 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Cardiac disorders
Ventricular tachycardia
|
2.5%
9/356 • Number of events 10 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Endocrine disorders
Basedow's disease
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Endocrine disorders
Goitre
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Endocrine disorders
Hypothyroidism
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Eye disorders
Cataract
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Eye disorders
Glaucoma
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Abdominal mass
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Constipation
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Ileus
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Gastrointestinal disorders
Toothache
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Chest pain
|
0.84%
3/356 • Number of events 3 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Implant site haemorrhage
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Implant site pain
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Medical device site discomfort
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Medical device site pain
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Oedema peripheral
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
General disorders
Phantom shocks
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Immune system disorders
Anaphylactic reaction
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Immune system disorders
Anaphylactic shock
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
COVID-19
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Cellulitis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Chronic hepatitis B
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Implant site infection
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Orchitis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Pneumonia
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Postoperative wound infection
|
1.1%
4/356 • Number of events 4 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Sepsis
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Septic shock
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Systemic infection
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Upper respiratory tract infection
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Device placement issue
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Incision site impaired healing
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Investigations
Blood pressure decreased
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Investigations
Glycosylated haemoglobin increased
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Investigations
SARS-CoV-2 test positive
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Gout
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.84%
3/356 • Number of events 3 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Cerebral ischaemia
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Embolic stroke
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Encephalopathy
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Facial spasm
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Headache
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Ischaemic stroke
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Sciatica
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Small fibre neuropathy
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Syncope
|
2.0%
7/356 • Number of events 7 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Nervous system disorders
Transient ischaemic attack
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Device computer issue
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Device inappropriate shock delivery
|
6.5%
23/356 • Number of events 29 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
5.4%
2/37 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Device inversion
|
1.1%
4/356 • Number of events 4 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Device lead damage
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Lead dislodgement
|
2.8%
10/356 • Number of events 11 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
2.7%
1/37 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Oversensing
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Psychiatric disorders
Delirium
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Psychiatric disorders
Depression
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Bladder stenosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Renal failure
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Reproductive system and breast disorders
Acute pulmonary oedema
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypopharyngeal synechiae
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.56%
2/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.28%
1/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Hypertension
|
1.1%
4/356 • Number of events 4 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Hypotension
|
3.1%
11/356 • Number of events 11 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Hypovolaemic shock
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Iliac artery occlusion
|
0.28%
1/356 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Microangiopathy
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Vascular disorders
Thrombosis
|
0.28%
1/356 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Product Issues
Device pacing issue
|
0.00%
0/356 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
2.7%
1/37 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/356 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
2.7%
1/37 • Number of events 1 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
Other adverse events
| Measure |
Enrolled Pivotal
n=356 participants at risk
Subjects enrolled in the Extravascular ICD Pivotal Study
|
Enrolled Continued Access
n=37 participants at risk
Subjects enrolled in the Extravascular ICD Continued Access Study (Used MedDRA 26.0)
|
|---|---|---|
|
Infections and infestations
Infections and infestations
|
5.6%
20/356 • Number of events 20 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
|
0.00%
0/37 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
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General disorders
Pain in area of device pocket
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0.00%
0/356 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
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5.4%
2/37 • Number of events 2 • Pivotal: Among the 356 enrolled subjects, the average follow-up duration from enrollment to last documented contact was 309 days. Forty exited the study without having an implant attempt. Among the 316 subjects who underwent an implant attempt of the EV ICD System, the average follow-up duration from implant attempt to last documented contact was 322 days (range: 10 - 924 days). EV ICD CA: Consent to implant, then 30 days post implant and at 6 month intervals until study closure (10 months).
All adverse events (AEs) are collected throughout the study duration, starting at the time the Informed Consent Form is signed. Reporting of these events to Medtronic will occur on an Adverse Event eCRF, including a description of AE, date of onset of AE, date of awareness of site, treatment, resolution, assessment of both the seriousness and the relatedness to the system and/or procedure. The Pivotal Study used MedDRA 25.0, the Continued Access Study used MedDRA 26.0
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and participating institutions will provide any publication of study data generated by the Investigator and/or participating institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
- Publication restrictions are in place
Restriction type: OTHER