Trial Outcomes & Findings for Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction (NCT NCT02433379)
NCT ID: NCT02433379
Last Updated: 2025-03-24
Results Overview
Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1173 participants
Primary outcome timeframe
18 months
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
UNTOUCHED Study Participants
There were 1173 patients who were consented for participation in the UNTOUCHED Study. Of the 1173 participants enrolled 1116 were implanted or attempted for implant with an EMBLEM S-ICD and programmed with rate zones set at 200 bpm and 250 bpm per protocol. There were 57 enrolled subjects who were determined to be screen failures or were not attempted for implant. These subjects were not followed for the study and therefore not included in the study analyses/results.
|
|---|---|
|
Overall Study
STARTED
|
1173
|
|
Overall Study
COMPLETED
|
852
|
|
Overall Study
NOT COMPLETED
|
321
|
Reasons for withdrawal
| Measure |
UNTOUCHED Study Participants
There were 1173 patients who were consented for participation in the UNTOUCHED Study. Of the 1173 participants enrolled 1116 were implanted or attempted for implant with an EMBLEM S-ICD and programmed with rate zones set at 200 bpm and 250 bpm per protocol. There were 57 enrolled subjects who were determined to be screen failures or were not attempted for implant. These subjects were not followed for the study and therefore not included in the study analyses/results.
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|---|---|
|
Overall Study
Screen Failures
|
55
|
|
Overall Study
Death
|
57
|
|
Overall Study
Total Withdrawals
|
209
|
Baseline Characteristics
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Baseline characteristics by cohort
| Measure |
UNTOUCHED Implanted/Attempted Subjects
n=1116 Participants
UNTOUCHED Study subjects who were implanted or attempted for implant with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp.
|
|---|---|
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Age, Continuous
|
55.8 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
286 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
830 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
704 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
239 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
53 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
83 Participants
n=99 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
807 participants
n=99 Participants
|
|
Region of Enrollment
Europe
|
292 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All implanted subjects were included in the analysis except for one participant who was co-enrolled in another study that may have affected the results of this analysis. There were 4 subjects who were attempted to be implanted but did not receive a device and therefore not included in the analysis. The endpoint was analyzes using intent to treat analysis.
Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.
Outcome measures
| Measure |
S-ICD
n=1111 Participants
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
S-ICD (EMBLEM Model A219)
The first 200 subjects implanted with an EMBLEM S-ICD (Model A219) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|---|
|
Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD
|
95.9 Percentage of participants
Interval 94.8 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All implanted and attempted subjects were included in the analysis.
Secondary safety endpoint: Freedom from System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%.
Outcome measures
| Measure |
S-ICD
n=1116 Participants
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
S-ICD (EMBLEM Model A219)
The first 200 subjects implanted with an EMBLEM S-ICD (Model A219) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|---|
|
Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days
|
95.8 Percentage of participants
Interval 94.7 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All implanted subjects were included in the analysis except for one participant who was co-enrolled in another study that may have affected the results of this analysis. There were 4 subjects who were attempted to be implanted but did not receive a device and therefore not included in the analysis. The endpoint was analyzes using intent to treat analysis.
Secondary efficacy endpoint: All-Cause Shock Free Rate at 540 days (18-months) compared to a performance goal of 85.8%.
Outcome measures
| Measure |
S-ICD
n=1111 Participants
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
S-ICD (EMBLEM Model A219)
The first 200 subjects implanted with an EMBLEM S-ICD (Model A219) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|---|
|
Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD
|
90.6 Percentage of participants
Interval 89.0 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The first 200 UNTOUCHED Study subjects implanted with an EMBLEM model A209 device as well as the first 200 UNTOUCHED Study subjects implanted with an EMBLEM model A219 device
Post-Market Clinical Follow-up (PMCF) Endpoint: Freedom from System and Procedure Related Complications at 180 days (6 months) compared to a performance goal of 85%. This analysis was conducted for two sub-groups of UNTOUCHED Study subjects: 1.) the first 200 subjects implanted with an EMBLEM model A209 device; 2.) the first 200 subjects implanted with an EMBLEM model A219 device. The PMCF analysis prespecified in the study protocol only required a sub-set of the implanted UNTOUCHED Study subjects (i.e., 200 subjects for the EMBLEM A209 analysis and 200 for the EMBLEM A219 analysis; the full study cohort was not required for these two analyses).
Outcome measures
| Measure |
S-ICD
n=200 Participants
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
S-ICD (EMBLEM Model A219)
n=200 Participants
The first 200 subjects implanted with an EMBLEM S-ICD (Model A219) S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|---|
|
Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (6 Months).
|
93.5 Percentage of participants
Interval 89.9 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
93.5 Percentage of participants
Interval 89.9 to
As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
|
Adverse Events
S-ICD
Serious events: 354 serious events
Other events: 155 other events
Deaths: 57 deaths
Serious adverse events
| Measure |
S-ICD
n=1116 participants at risk
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Adverse drug reaction
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Immune system disorders
Adverse reaction - Allergic reaction
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Adverse reaction - Medication
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Hypotension Procedure
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Medication/Anaphylactic shock Procedure
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Respiratory Procedure
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Psychiatric disorders
Alcohol abuse
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
1.5%
17/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.2%
13/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Cancer
|
0.63%
7/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Cardiac arrest
|
0.81%
9/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Cardiogenic shock
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - hemorrhagic
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - ischemic
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - unspecifed
|
1.2%
13/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Chest pain - Heart failure
|
2.2%
25/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Chest pain - Ischemic
|
0.72%
8/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Chest pain - Other
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Coronary Artery Disease
|
1.5%
17/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Death
|
0.90%
10/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis (DVT)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Device shocked 5 times before conversion
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Device system discomfort (> 30d post implant)
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Device system infection (= 30d post implant with explant)
|
0.72%
8/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Device system infection (>30d post implant with explant)
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Dislodgment - Oversensing - RV Lead
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Distal thromboemboli
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Dizziness
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Dizziness - Heart failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Drug related
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Dyspnea - Heart failure
|
2.8%
31/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Electrode erosion
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Electrode migration/revision
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Electrode migration/revision Procedure
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Electrode suture discomfort
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Endocrine disorders
Endocrine
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Fascial defect closure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Fatigue - Heart failure
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Fatigue/Weakness
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Fever and/or Virus
|
0.99%
11/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.2%
25/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Reproductive system and breast disorders
Genitourinary
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
2.4%
27/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Blood and lymphatic system disorders
Hematological
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma - Unrelated (non study) procedure or device
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma PG pocket (= 30d post implant)
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hemodynamic instability DFT testing Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hemorrhage - Unrelated (non study) procedure or device
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Hypertension - Heart failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Hypotension - Heart failure
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemic respiratory failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Inadequate healing of incision site Subject
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Inadvertent arrhythmia Procedure
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy NSC (Cardiac oversensing) Electrode
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy NSR (Cardiac oversensing) System
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy noise (Non-cardiac) System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy SVT above programmed rate zone System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy SVT discrimination error System
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Incisional/Superficial infection (= 30d post implant without explant)
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Incisional/Superficial infection (>30d post implant without explant)
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Intermittent ST elevation during implant
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Intracardiac thrombus
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
LBBB
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Localized Infection
|
0.63%
7/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Localized infection
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Mitral regurgitation
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Multi-system failure
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Multi-system failure - Heart failure
|
1.4%
16/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Multiple heart failure symptoms
|
8.2%
91/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Multiple symptoms
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Myocardial biopsy (dilated cardiomyopathy of unknown origin)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Nervous system disorders
Neurological
|
1.3%
14/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Non VT/VF cardiac oversensing AF
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Out of Range shock impedance Electrode
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Oversensing System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
PG erosion
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
PG migration Subject
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Patient fall
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Peripheral vascular disease
|
0.45%
5/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Physical trauma
|
0.72%
8/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Positioning during procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort PG site (= 30d post implant) Procedure
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort PG site (> 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Postoperative urinary retention
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Premature cell battery depletion - PG
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Psychiatric disorders
Psychological
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.9%
21/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Pulmonary Embolism (PE)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Pulmonary edema - Heart failure
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Pulseless Electrical Activity (PEA)
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Renal and urinary disorders
Renal
|
1.8%
20/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Sinus bradycardia
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Strep infection
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Sub-optimal electrode position
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Suboptimal electrode position
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Suspected infection Incisional/Superficial (= 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Syncope
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Syncope - Heart failure
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Systemic infection
|
1.3%
14/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.81%
9/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Unable to convert VT/VF with S-ICD
|
0.90%
10/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Valvular damage/Valvular insufficiency
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Vasovagal reaction
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Volume overload
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Weight gain - Heart failure
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Weight loss
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
Other adverse events
| Measure |
S-ICD
n=1116 participants at risk
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
EMBLEM S-ICD System: The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
|
|---|---|
|
Injury, poisoning and procedural complications
AF during conversion testing
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Acute blood loss
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Adverse reaction - General
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction HF symptoms Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Hypotension Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Medication/Anaphylactic shock Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse reaction Respiratory Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Aortic stenosis
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Chest pain - Heart failure
|
1.9%
21/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Chest pain - Ischemic
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Chest pain - Other
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Coronary Artery Disease
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Dehydration - Heart failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Device system discomfort (> 30d post implant)
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Dizziness
|
0.36%
4/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Dyspnea - Heart failure
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Electrode migration/revision
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Electrode movement Procedure
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Electrode suture discomfort
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Fatigue/Weakness
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Reproductive system and breast disorders
Genitourinary
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma Electrode incision (= 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Hematoma PG pocket (= 30d post implant)
|
0.72%
8/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Inadequate healing of incision site Subject
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Inadvertent arrhythmia Procedure
|
0.72%
8/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy NSC (Cardiac oversensing) Electrode
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy NSR (Cardiac oversensing) System
|
1.4%
16/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy noise (Non-Cardiac) PG
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate tachy therapy noise (Non-cardiac) System
|
1.1%
12/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy Baseline shift PG
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy Baseline shift System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy SVT above programmed rate zone System
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Inappropriate therapy SVT discrimination error System
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Incisional/Superficial infection (= 30d post implant without explant)
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Incisional/Superficial infection (>30d post implant without explant)
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Incomplete header/electrode connection
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Intermittent sensing/undersensing System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Multiple heart failure symptoms
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Nervous system disorders
Neurological
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Non VT/VF cardiac oversensing
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Non VT/VF cardiac oversensing AF
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Non VT/VF cardiac oversensing for AF
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Surgical and medical procedures
Outcome of elective MV and LAA closure surgery
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Oversensing System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
PG erosion (= 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
PG movement
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Physical trauma
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Physical trauma Procedure
|
0.27%
3/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical bleeding/hemorrhage (= 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort PG site (= 30d post implant) Procedure
|
1.8%
20/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort PG site (> 30d post implant)
|
0.63%
7/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Pulmonary edema - Heart failure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
Random component failure Therapy available System
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Renal and urinary disorders
Renal
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Scar Cyst/Keloid Procedure
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Seroma PG pocket (= 30d post implant)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Suspected infection Incision/Superficial (>30d post implant)
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Suspected infection Incisional/Superficial (= 30d post implant)
|
0.90%
10/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Suture revision
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Syncope related to VT/VF Subject
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Infections and infestations
Systemic infection
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
T-wave oversensing
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Unable to convert VT/VF with S-ICD
|
0.18%
2/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Product Issues
User error programmer
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
VT/VF below programming rate
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.54%
6/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Vomiting during anesthesia induction
|
0.09%
1/1116 • Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 18-Months of follow-up.
|
Additional Information
Paji Vitoff, Manager, Clinical Trials
Boston Scientific
Phone: 651-582-5415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60