Trial Outcomes & Findings for Shockless Implant Evaluation (NCT NCT00800384)
NCT ID: NCT00800384
Last Updated: 2018-03-30
Results Overview
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2500 participants
Primary outcome timeframe
Mean follow-up of 3.1 years
Results posted on
2018-03-30
Participant Flow
First patient was recruited 13 January 2014, last patient was recruited 4 April 2011. All patients were part of the general ICD population at participating sites.
Participant milestones
| Measure |
ICD Implant Without Defibrillation Testing
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
Overall Study
STARTED
|
1247
|
1253
|
|
Overall Study
COMPLETED
|
1206
|
1210
|
|
Overall Study
NOT COMPLETED
|
41
|
43
|
Reasons for withdrawal
| Measure |
ICD Implant Without Defibrillation Testing
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
17
|
|
Overall Study
Lost to Follow-up
|
17
|
26
|
Baseline Characteristics
Shockless Implant Evaluation
Baseline characteristics by cohort
| Measure |
ICD Implant Without Defibrillation Testing
n=1247 Participants
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
n=1253 Participants
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
Total
n=2500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.58 years
STANDARD_DEVIATION 11.51 • n=99 Participants
|
62.98 years
STANDARD_DEVIATION 11.69 • n=107 Participants
|
62.78 years
STANDARD_DEVIATION 11.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
476 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1015 Participants
n=99 Participants
|
1009 Participants
n=107 Participants
|
2024 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Mean follow-up of 3.1 yearsPopulation: All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Outcome measures
| Measure |
ICD Implant Without Defibrillation Testing
n=1247 Participants
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
n=1253 Participants
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
|
90 participants
|
104 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Outcome measures
| Measure |
ICD Implant Without Defibrillation Testing
n=1236 Participants
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
n=1242 Participants
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
Perioperative Complication Rate
|
69 participants
|
81 participants
|
Adverse Events
ICD Implant Without Defibrillation Testing
Serious events: 776 serious events
Other events: 625 other events
Deaths: 0 deaths
ICD Implant With Defibrillation Testing
Serious events: 790 serious events
Other events: 632 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICD Implant Without Defibrillation Testing
n=1247 participants at risk
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
n=1253 participants at risk
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
Cardiac disorders
Dislodgment - Elevated threshold - LV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Extracardiac stimulation- LV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG System
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - RV
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to convert - Defibrillation
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated DFT - Defibrillation
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG system - Therapy
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - SVT
|
2.0%
25/1247 • Number of events 27 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.0%
25/1253 • Number of events 30 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - NSR
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - Noise
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - Other
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Early ERI - Random component failure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Early ERI - Consistent with device programming
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Early ERI - Premature declaration
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Pacemaker-mediated tachycardia
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG System - Patient related
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erosion
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
PG system - Infection (> 30 days post implant)
|
1.9%
24/1247 • Number of events 29 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.7%
21/1253 • Number of events 23 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
Seroma - Pocket (> 30 days post- implant)
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Migration
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Post-surgical wound discomfort
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Post-surgical pocket hemorrhage
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
Post-surgical infection (<= 30 days post-implant)
|
0.88%
11/1247 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Adverse reaction - General
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Adverse reaction - Respiratory
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Adverse reaction - Hypotension
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hemodynamic instability - DFT testing
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Inadvertent VT/VF
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Inadvertent SVT
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Chest pain
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hemorrhage
|
0.48%
6/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Physical trauma
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hematoma - Pocket (<=30 days post-implant)
|
1.8%
23/1247 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.5%
31/1253 • Number of events 31 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Seroma - Pocket (<=30 days post-implant)
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Thromboembolic events
|
0.48%
6/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Other - PG system - Procedure
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Undersensing - RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - RA
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Conductor coil fracture - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Unable to capture - RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Extracardiac stimulation- RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - RA
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs - RA
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.64%
8/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other - Lead
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
RV - unspecific
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Oversensing - RV
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - RV
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Conductor coil fracture - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Insulation breach - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Electrode damaged - RV
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Myocardial perforation post- implant - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Impedance < 300 ohms - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Impedance > 2000 ohms - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Unable to capture RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Elevated threshold -RV
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Oversensing - RV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - RV
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs - RV
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.64%
8/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - LV
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - LV
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Extracardiac stimulation - LV
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Electrode damaged - LV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Unable to capture - LV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - LV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs -LV
|
0.40%
5/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Oversensing - Defibrillation lead
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Undersensing - Defibrillation lead
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated DFT - Defibrillation lead
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Puncture site hematoma - Procedure
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pneumothorax - Procedure
|
1.5%
19/1247 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.88%
11/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Renal failure due to contrast media - Procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pleural effusion - Procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hemothorax - Procedure
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Coronary venous dissection
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Myocardial perforation with tamponade
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
AV block (transient) - Procedure
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericardial effusion
|
0.56%
7/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Other - Lead - Procedure
|
1.4%
18/1247 • Number of events 18 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.4%
18/1253 • Number of events 18 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Patient CONDITION Cardiovascular
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Tachycardia - unspecific
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Bradyarrhythmias - unspecific
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
1st degree AV block
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
3rd degree AV block
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Pulseless electrical activity (PEA)
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular tachyarrhythmias - unspecified
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.56%
7/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular fibrillation (VF)
|
1.0%
13/1247 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.56%
7/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
3.9%
49/1247 • Number of events 65 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
38/1253 • Number of events 57 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Electrical Storm
|
1.2%
15/1247 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.0%
13/1253 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial Tachyarrhythmias - unspecific
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
3.4%
42/1247 • Number of events 48 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.9%
49/1253 • Number of events 65 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
1.0%
13/1247 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.4%
17/1253 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other SVT (eg AVRT, AVNRT, EAT)
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.56%
7/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atypical Atrial Flutter
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Premature ventricular contractions (PVC)
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Syncope - Heart failure
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dizziness - Heart failure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Chest pain - Heart failure
|
0.48%
6/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dyspnea - Heart failure
|
3.4%
42/1247 • Number of events 50 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.3%
41/1253 • Number of events 50 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.56%
7/1247 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema - Heart failure
|
1.8%
23/1247 • Number of events 26 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Fatigue - Heart failure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Renal insufficiency - Heart failure
|
0.72%
9/1247 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dehydration - Heart failure
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal - Heart failure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
3.0%
37/1247 • Number of events 45 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.4%
42/1253 • Number of events 62 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Multiple heart failure symptoms
|
11.6%
145/1247 • Number of events 212 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
11.0%
138/1253 • Number of events 202 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Hypertension - Heart failure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other- Heart failure patient condition - Cardiovascular
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Multi-system failure - Heart failure
|
6.1%
76/1247 • Number of events 81 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.5%
57/1253 • Number of events 63 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.72%
9/1247 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Cardiogenic shock
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.72%
9/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.88%
11/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
34/1247 • Number of events 34 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.2%
27/1253 • Number of events 29 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Coronary Artery Disease
|
6.7%
83/1247 • Number of events 103 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.7%
46/1253 • Number of events 63 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Vascular disease - unspecific
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Peripheral vascular disease
|
2.9%
36/1247 • Number of events 55 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
37/1253 • Number of events 62 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Valve related - unspecific
|
1.0%
13/1247 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.0%
13/1253 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Aortic stenosis
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Mitral stenosis
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Mitral regurgitation
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Syncope
|
2.1%
26/1247 • Number of events 28 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
37/1253 • Number of events 41 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Dizziness
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Chest pain - Ischemic
|
1.6%
20/1247 • Number of events 25 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.7%
21/1253 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Chest pain - Other
|
1.8%
22/1247 • Number of events 23 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.5%
19/1253 • Number of events 22 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Dyspnea
|
0.72%
9/1247 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.72%
9/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Palpitations
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Fatigue
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Other- Patient condition - Cardiovascular
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Thromboembolic events - unspecific
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Transient ischemic attack (TIA)
|
0.72%
9/1247 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
2.6%
33/1247 • Number of events 34 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.8%
23/1253 • Number of events 26 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Pulmonary embolism (PE)
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Distal thromboemboli
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.64%
8/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Intracardiac thrombus
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Procedure related complication other than implant procedure
|
1.3%
16/1247 • Number of events 21 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericardial effusion - Unrelated to procedure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericarditis
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hematoma
|
0.72%
9/1247 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Immune system disorders
Adverse reaction - Allergic reaction
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Vasovagal reaction
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.9%
24/1247 • Number of events 37 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.2%
15/1253 • Number of events 25 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
WHOLE BODY
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Death - Reason unspecified
|
3.7%
46/1247 • Number of events 46 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.0%
50/1253 • Number of events 50 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
Systemic infection
|
3.7%
46/1247 • Number of events 52 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.9%
36/1253 • Number of events 40 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Fever
|
0.72%
9/1247 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Physical trauma
|
2.3%
29/1247 • Number of events 32 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
37/1253 • Number of events 42 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.64%
8/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Blood and lymphatic system disorders
Hematological
|
1.5%
19/1247 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.2%
15/1253 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Nervous system disorders
Neurological
|
1.2%
15/1247 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.4%
18/1253 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal
|
7.6%
95/1247 • Number of events 132 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
9.2%
115/1253 • Number of events 147 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
7.5%
94/1247 • Number of events 123 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
7.6%
95/1253 • Number of events 115 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Genitourinary
|
2.1%
26/1247 • Number of events 33 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
38/1253 • Number of events 46 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Renal
|
4.3%
54/1247 • Number of events 61 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.3%
41/1253 • Number of events 52 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.3%
41/1247 • Number of events 46 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.7%
34/1253 • Number of events 38 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Psychiatric disorders
Psychological
|
0.88%
11/1247 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.1%
14/1253 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
1.6%
20/1247 • Number of events 23 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
2.5%
31/1247 • Number of events 39 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.8%
23/1253 • Number of events 25 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Endocrine disorders
Endocrine
|
2.0%
25/1247 • Number of events 28 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.6%
32/1253 • Number of events 35 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Immune system disorders
Immune
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
4.9%
61/1247 • Number of events 81 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.8%
60/1253 • Number of events 91 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Multi-system failure
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Adverse drug reaction
|
1.1%
14/1247 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.0%
13/1253 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
Other adverse events
| Measure |
ICD Implant Without Defibrillation Testing
n=1247 participants at risk
Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
|
ICD Implant With Defibrillation Testing
n=1253 participants at risk
Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
|
|---|---|---|
|
Cardiac disorders
PG System
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Oversensing - RA
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other - PG system
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to convert - Defibrillation
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated DFT - Defibrillation
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG system - Therapy
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate AV Delay
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - SVT
|
1.6%
20/1247 • Number of events 23 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.8%
22/1253 • Number of events 33 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - NSR
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - Noise
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inappropriate tachy therapy - Other
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Early ERI - Premature declaration
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Pacemaker-mediated tachycardia
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG system - Diagnosis
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inability to maintain telemetry
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
PG System - Patient related
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
PG system - Infection (> 30 days post implant)
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
0.24%
3/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hematoma - Pocket (> 30 days post implant)
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Migration
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Post-surgical wound discomfort
|
1.6%
20/1247 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.7%
21/1253 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Post-surgical pocket hemorrhage
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
Post-surgical infection (<= 30 days post-implant)
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Adverse reaction - General
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Adverse reaction - Respiratory
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Adverse reaction - Bradycardia
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Adverse reaction - Hypotension
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Vasovagal
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hemodynamic instability - DFT testing
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inadvertent VT/VF
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Inadvertent SVT
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Chest pain
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hemorrhage
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Physical trauma
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.56%
7/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hematoma - Pocket (<=30 days post-implant)
|
4.8%
60/1247 • Number of events 61 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.1%
51/1253 • Number of events 51 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Seroma - Pocket (<=30 days post-implant)
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Thromboembolic events
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Other - PG system - Procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Undersensing - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - RA
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.80%
10/1253 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Extracardiac stimulation - RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Electrode damaged - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Impedance > 2000 ohms - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Unable to capture - RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Elevated threshold - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Extracardiac stimulation- RA
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs - RA
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other - Lead
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.64%
8/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Oversensing - RV
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - RV
|
1.3%
16/1247 • Number of events 16 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.2%
15/1253 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Conductor coil fracture - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Impedance < 300 ohms - RV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Elevated threshold -RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - RV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs - RV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Unable to capture - LV
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated threshold - LV
|
1.5%
19/1247 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.7%
21/1253 • Number of events 21 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Extracardiac stimulation - LV
|
2.6%
32/1247 • Number of events 41 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.9%
36/1253 • Number of events 45 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Electrode damaged - LV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Unable to capture - LV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Elevated threshold - LV
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - Multiple signs - LV
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dislodgment - No reported signs -LV
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Defibrillation lead
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Oversensing - Defibrillation lead
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Undersensing - Defibrillation lead
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Elevated DFT - Defibrillation lead
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Arterial perforation - Procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pneumothorax - Procedure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Renal failure due to contrast media - Procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pleural effusion - Procedure
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Coronary venous dissection
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
AV block (transient) - Procedure
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericardial effusion
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Other - Lead - Procedure
|
1.8%
23/1247 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.2%
27/1253 • Number of events 27 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Patient CONDITION Cardiovascular
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Bradyarrhythmias - unspecific
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
1st degree AV block
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
2nd degree AV block
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
3rd degree AV block
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular tachyarrhythmias - unspecified
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular fibrillation (VF)
|
0.16%
2/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
1.8%
23/1247 • Number of events 25 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.6%
33/1253 • Number of events 39 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.56%
7/1247 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.1%
14/1253 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Accelerated idiopathic rhythm
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial Tachyarrhythmias - unspecific
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
3.6%
45/1247 • Number of events 49 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.4%
43/1253 • Number of events 49 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.96%
12/1247 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other SVT (eg AVRT, AVNRT, EAT)
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Premature ventricular contractions (PVC)
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Syncope - Heart failure
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dizziness - Heart failure
|
0.32%
4/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Chest pain - Heart failure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dyspnea - Heart failure
|
2.7%
34/1247 • Number of events 37 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.3%
29/1253 • Number of events 29 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
1.2%
15/1247 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.88%
11/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema - Heart failure
|
0.40%
5/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Fatigue - Heart failure
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Renal insufficiency - Heart failure
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Dehydration - Heart failure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Weight gain - Heart failure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
0.80%
10/1247 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Multiple heart failure symptoms
|
2.5%
31/1247 • Number of events 34 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.6%
33/1253 • Number of events 39 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Hypertension - Heart failure
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Other- Heart failure patient condition - Cardiovascular
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Hypotension
|
1.8%
22/1247 • Number of events 22 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.5%
19/1253 • Number of events 19 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.72%
9/1247 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.2%
15/1253 • Number of events 18 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Coronary Artery Disease
|
1.4%
18/1247 • Number of events 19 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.1%
14/1253 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Vascular disease - unspecific
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Peripheral vascular disease
|
0.96%
12/1247 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Valve related - unspecific
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Syncope
|
3.4%
43/1247 • Number of events 48 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.2%
27/1253 • Number of events 31 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Dizziness
|
2.1%
26/1247 • Number of events 30 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.9%
36/1253 • Number of events 38 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Chest pain - Ischemic
|
0.80%
10/1247 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.88%
11/1253 • Number of events 11 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Chest pain - Other
|
1.4%
17/1247 • Number of events 28 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.5%
19/1253 • Number of events 23 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Dyspnea
|
1.5%
19/1247 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 12 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Palpitations
|
0.96%
12/1247 • Number of events 13 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.72%
9/1253 • Number of events 9 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Fatigue
|
0.80%
10/1247 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.48%
6/1253 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Multiple Symptoms
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Thromboembolic events - unspecific
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Transient ischemic attack (TIA)
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Distal thromboemboli
|
0.32%
4/1247 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.24%
3/1247 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Procedure related complication other than implant procedure
|
0.56%
7/1247 • Number of events 10 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.32%
4/1253 • Number of events 4 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericardial effusion - Unrelated to procedure
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Pericarditis
|
0.08%
1/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Surgical and medical procedures
Hematoma
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Immune system disorders
Adverse reaction - Allergic reaction
|
0.48%
6/1247 • Number of events 6 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.56%
7/1253 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Vascular disorders
Vasovagal reaction
|
0.40%
5/1247 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.56%
7/1247 • Number of events 7 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
WHOLE BODY
|
0.00%
0/1247 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.16%
2/1253 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Infections and infestations
Systemic infection
|
1.4%
17/1247 • Number of events 18 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.24%
3/1253 • Number of events 3 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Fever
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Physical trauma
|
3.3%
41/1247 • Number of events 46 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.4%
30/1253 • Number of events 31 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
1.1%
14/1247 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.40%
5/1253 • Number of events 5 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Blood and lymphatic system disorders
Hematological
|
1.4%
18/1247 • Number of events 20 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.96%
12/1253 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Nervous system disorders
Neurological
|
1.3%
16/1247 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.3%
16/1253 • Number of events 24 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.9%
49/1247 • Number of events 62 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.5%
56/1253 • Number of events 64 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.8%
48/1247 • Number of events 54 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
4.7%
59/1253 • Number of events 68 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Genitourinary
|
3.0%
38/1247 • Number of events 49 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.2%
28/1253 • Number of events 32 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Renal and urinary disorders
Renal
|
1.6%
20/1247 • Number of events 22 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.1%
14/1253 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.1%
51/1247 • Number of events 61 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.9%
49/1253 • Number of events 52 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Psychiatric disorders
Psychological
|
0.64%
8/1247 • Number of events 8 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.1%
14/1253 • Number of events 14 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
2.4%
30/1247 • Number of events 32 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.4%
30/1253 • Number of events 32 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
4.3%
53/1247 • Number of events 61 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.9%
49/1253 • Number of events 53 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Endocrine disorders
Endocrine
|
3.3%
41/1247 • Number of events 49 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
3.0%
38/1253 • Number of events 44 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Immune system disorders
Immune
|
0.16%
2/1247 • Number of events 2 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.08%
1/1253 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.1%
14/1247 • Number of events 17 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
1.0%
13/1253 • Number of events 15 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
|
0.08%
1/1247 • Number of events 1 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
0.00%
0/1253 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
|
General disorders
Adverse drug reaction
|
2.1%
26/1247 • Number of events 30 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
2.0%
25/1253 • Number of events 27 • Adverse events were collected from first enrollment until last patient last follow-up. Total Follow-up duration 4 years and 10 months. Average follow-up time 3.1 years.
All serious adverse events as per International Standards Organization (ISO) 14155 were collected, regardless whether they were related to the device or protocol. Non serious adverse events were collected without predefining a frequency threshold.
|
Additional Information
Dr. Jeff Healey
Population Health Research Institute, McMaster University
Phone: 001 905 330 6760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60