Trial Outcomes & Findings for ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (NCT NCT01424722)
NCT ID: NCT01424722
Last Updated: 2021-01-28
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2258 participants
Primary outcome timeframe
12 months
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
ST Monitoring Feature
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Overall Study
STARTED
|
2258
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2258
|
Reasons for withdrawal
| Measure |
ST Monitoring Feature
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Overall Study
Sponsor terminated investigation
|
2258
|
Baseline Characteristics
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Baseline characteristics by cohort
| Measure |
ST Monitoring Feature
n=2258 Participants
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1029 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1229 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
424 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1834 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1899 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2258 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population includes the number of patients with Clinical Event Committee adjudicated data related to ACS events.
Outcome measures
| Measure |
ST Monitoring Feature
n=1404 Participants
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
|
115 Participants
|
Adverse Events
ST Monitoring Feature
Serious events: 217 serious events
Other events: 177 other events
Deaths: 270 deaths
Serious adverse events
| Measure |
ST Monitoring Feature
n=2258 participants at risk
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Injury, poisoning and procedural complications
Aspiration
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Battery Depletion at Implant
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.13%
3/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Cardiac Perforation
|
0.22%
5/2258 • Number of events 5 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Cardiac Tamponade
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Cardiac/respiratory arrest
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Coronary sinus perforation/dissection
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Decompensated Heart Failure
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Infections and infestations
Device infection/erosion
|
1.1%
24/2258 • Number of events 27 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Device Malfunction
|
0.49%
11/2258 • Number of events 11 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Discomfort at implant site
|
0.27%
6/2258 • Number of events 7 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Elevated pacing thresholds
|
0.31%
7/2258 • Number of events 7 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Cardiac disorders
Endocarditis
|
0.35%
8/2258 • Number of events 8 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Generator changeout/upgrade
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Renal and urinary disorders
Genitourinary disease/disorder
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.35%
8/2258 • Number of events 8 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
High Defibrillation Threshold
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Hypotension
|
0.18%
4/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Inappropriate therapy due to non-ventricular rhythm
|
0.44%
10/2258 • Number of events 13 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Infections and infestations
Infection
|
0.44%
10/2258 • Number of events 10 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead dislodgment or migration
|
2.7%
62/2258 • Number of events 68 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Lead entanglement
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead fracture
|
0.58%
13/2258 • Number of events 13 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead Impedance out of range
|
0.58%
13/2258 • Number of events 13 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead insulation damage
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead noise
|
0.13%
3/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Loss of capture
|
0.22%
5/2258 • Number of events 5 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Oversensing
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
pericardial effusion
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.09%
2/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.35%
8/2258 • Number of events 8 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Infections and infestations
Sepsis
|
0.18%
4/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Blood and lymphatic system disorders
Thrombus
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Undersensing
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Blood and lymphatic system disorders
Upper extremity thromboembolism
|
0.18%
4/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Vascular Injury/Repair
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Inappropriate therapy due to oversensing
|
0.18%
4/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead abrasion
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Premature battery depletion
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Vascular disorders
Vascular disease/disorder
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
Other adverse events
| Measure |
ST Monitoring Feature
n=2258 participants at risk
Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices: Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
|
|---|---|
|
Cardiac disorders
Atrial Arrhythmia
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.31%
7/2258 • Number of events 7 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Fluid accumulation
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Vascular disorders
Hypertension/hypertensive crisis
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Inappropriate therapy due to non-ventricular rhythm
|
2.0%
46/2258 • Number of events 50 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Infections and infestations
Infection
|
0.31%
7/2258 • Number of events 7 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead Fracture
|
0.13%
3/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead noise
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Pacemaker mediated tachycardia
|
0.44%
10/2258 • Number of events 11 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Nervous system disorders
Stroke/Cerebrovascular accident
|
0.13%
3/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Blood and lymphatic system disorders
Thrombus
|
0.13%
3/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Allergic reaction
|
0.13%
3/2258 • Number of events 3 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Cardiac perforation
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Musculoskeletal and connective tissue disorders
Chest pain - non cardiac
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Cognitive changes
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Infections and infestations
Device infection/erosion
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Device malfunction
|
0.22%
5/2258 • Number of events 5 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Discomfort at incision/implant site
|
0.40%
9/2258 • Number of events 10 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Edema
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
General disorders
Exercise limitation
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Hematoma
|
1.1%
24/2258 • Number of events 24 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Inappropriate therapy due to oversensing
|
0.27%
6/2258 • Number of events 6 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead impedance out of range
|
0.40%
9/2258 • Number of events 10 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Lead insulation damage
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Loss of capture
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disease/disorder
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Non-SJM hardware related problem
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Oversensing
|
0.22%
5/2258 • Number of events 5 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Pericardial effusion
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Psychiatric disorders
Phantom shock
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.18%
4/2258 • Number of events 4 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Possible generator migration
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Skin and subcutaneous tissue disorders
Skin disease/disorder
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Skin and subcutaneous tissue disorders
Wound dehiscence
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Injury, poisoning and procedural complications
Suture protrusion
|
0.04%
1/2258 • Number of events 1 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
General disorders
Syncope/pre-syncope
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Product Issues
Undersensing
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
|
Vascular disorders
Upper extremity thromboembolism
|
0.09%
2/2258 • Number of events 2 • Adverse Event (AE) data were collected from time of implant/attempted implant though last visit for each subject (up to 5 years per subject).
AEs were Observations, Complications or Other Reported Events (OREs) * Complications-events that required invasive intervention (reported under Serious AEs here) * Observations-events managed without invasive intervention (reported under Non-serious AEs here) * ORE-event submitted by an investigator and not associated with the investigational device, clinical study, and/or defined as an AE \*Subjects may have more than 1 event in more than 1 category; # subjects in each will not add to up total
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60