Trial Outcomes & Findings for QuickFlex Micro Left Ventricular Lead Post Approval Study (NCT NCT01179477)

NCT ID: NCT01179477

Last Updated: 2019-08-12

Results Overview

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).

• Recruitment status: COMPLETED
• Target enrollment: 1930 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2019-08-12

Participant Flow

Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow.

Participant milestones

Measure	Subjects Implanted With a New QuickFlex μ Lead Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
Overall Study STARTED	1930
Overall Study COMPLETED	843
Overall Study NOT COMPLETED	1087

Reasons for withdrawal

Measure	Subjects Implanted With a New QuickFlex μ Lead Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
Overall Study Death	542
Overall Study Unsuccessful implant	80
Overall Study Non-death withdrawal	438
Overall Study Did not complete final visit	27

Baseline Characteristics

QuickFlex Micro Left Ventricular Lead Post Approval Study

Baseline characteristics by cohort

Measure	Subjects Implanted With a New QuickFlex μ Lead n=1930 Participants Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
Age, Continuous	68.7 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	529 Participants n=5 Participants
Sex: Female, Male Male	1401 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	197 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	67 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants
Race/Ethnicity, Customized White	1646 Participants n=5 Participants
Region of Enrollment United States	1930 participants n=5 Participants
Left Ventricular Ejection Fraction	25.1 Percent of blood ejected STANDARD_DEVIATION 7.6 • n=5 Participants
Intrinsic QRS duration	152.0 ms STANDARD_DEVIATION 25.2 • n=5 Participants
New York Heart Association (NYHA) Classification at Baseline Class I	19 Participants n=5 Participants
New York Heart Association (NYHA) Classification at Baseline Class II	175 Participants n=5 Participants
New York Heart Association (NYHA) Classification at Baseline Class III	1672 Participants n=5 Participants
New York Heart Association (NYHA) Classification at Baseline Class IV	61 Participants n=5 Participants
New York Heart Association (NYHA) Classification at Baseline Unknown	3 Participants n=5 Participants
Cardiomyopathy Ischemic	1131 Participants n=5 Participants
Cardiomyopathy Non-ischemic	799 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects.

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).

Outcome measures

Measure	Subjects Implanted With a New QuickFlex μ Lead n=1984 Participants Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication	1902 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data.

Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

Outcome measures

Measure	Subjects Implanted With a New QuickFlex μ Lead n=774 Participants Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Left Ventricular Bipolar Pacing Capture Threshold	2.04 Volts Standard Deviation 1.6

Adverse Events

Subjects Implanted With a New QuickFlex μ Lead

Serious events: 258 serious events

Other events: 512 other events

Deaths: 542 deaths

Serious adverse events

Measure	Subjects Implanted With a New QuickFlex μ Lead n=1930 participants at risk Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Injury, poisoning and procedural complications Lead Dislodgement or Migration	3.2% 62/1930 • Number of events 63 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Diaphragmatic/Phrenic Nerve Stimulation	0.83% 16/1930 • Number of events 16 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Loss of Capture	0.47% 9/1930 • Number of events 9 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Elevated Pacing Thresholds	0.41% 8/1930 • Number of events 8 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Abnormal LV Lead Pacing Impedance <= 200 OHMS or >= 2000 OHMS	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Dizziness	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Endocarditis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Induced Atrial or Ventricular Arrhythmias	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Lead Fracture	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Lead Insulation Damage	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Pain/Discomfort At Incision Site	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Premature Battery Depletion	0.41% 8/1930 • Number of events 8 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations Infection	1.2% 24/1930 • Number of events 24 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Suspected Generator Malfunction	0.21% 4/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations Erosion	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations Endocarditis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues LV Lead Loss of Capture	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Psychiatric disorders Twiddler Syndrome	0.16% 3/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Pericardial Effusion	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Dislodgement or Migration	1.0% 20/1930 • Number of events 22 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Abnormal Lead Impedance	0.21% 4/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Insulation Damage	0.21% 4/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Loss of Capture	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Atrial Lead Noise	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RA Cardiac/Coronary Sinus Perforation	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RA Diaphragmatic/Phrenic Nerve Stimulation	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Elevated Pacing Thresholds	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Oversensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Undersensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Lead Dislodgement or Migration	1.6% 31/1930 • Number of events 32 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Elevated Pacing Thresholds	0.47% 9/1930 • Number of events 9 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Fracture	0.36% 7/1930 • Number of events 7 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Insulation Damage	0.26% 5/1930 • Number of events 5 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Abnormal Lead Impedance	0.21% 4/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Cardiac/Coronary Sinus Perforation	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Loss of Capture	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Cardiac Tamponade	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations RV Endocarditis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Inappropriate Shock	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations RV Infection	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Oversensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Pectoral Stimulation	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Unable to Defibrillate	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Undersensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Hematoma/Seroma	0.47% 9/1930 • Number of events 9 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Pneumothorax/Hemothorax	0.36% 7/1930 • Number of events 7 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Pericardial Effusion	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Cardiac/Coronary Sinus Perforation	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Cardiac Arrest	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Cardiac Tamponade	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Deep Vein Thrombosis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Device Migration	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Guidewire Stuck In LV Lead	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Lead Dislodgement or Migration	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Pleural Effusion	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedural Skin Injury At PG Pocket	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)

Other adverse events

Measure	Subjects Implanted With a New QuickFlex μ Lead n=1930 participants at risk Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Product Issues LV Lead Elevated Pacing Thresholds	11.1% 214/1930 • Number of events 221 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications LV Diaphragmatic/Phrenic Nerve Stimulation	7.5% 145/1930 • Number of events 164 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues LV Loss of Capture	0.98% 19/1930 • Number of events 20 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 Ω	0.83% 16/1930 • Number of events 17 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications LV Induced Atrial or Ventricular Arrhythmias	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications LV Lead Dislodgement or Migration	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications LV Cardiac/Coronary Sinus Dissection	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications LV Coronary Sinus or Cardiac Vein Thrombosis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues LV Lead Insulation Damage	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Cardiac disorders System/Pulse Generator Related Therapy For Non-Ventricular Rhythm	1.2% 23/1930 • Number of events 27 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues System/Pulse Generator Related Failed ICD Shock	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Cardiac disorders System/Pulse Generator Related Idioventricular Rhythm Preventing Biventricular Pacing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues System/Pulse Generator Related Pacemaker Mediated Tachycardia	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Oversensing	0.47% 9/1930 • Number of events 9 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Abnormal Lead Impedance	0.26% 5/1930 • Number of events 5 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Atrial Lead Noise	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Elevated Pacing Thresholds	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Lead Insulation Damage	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Loss of Capture	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RA Lead Related Lead Dislodgement or Migration	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Lead Fracture	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RA Lead Related Myopotential Sensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RA Lead Related Undersensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Cardiac disorders RV Lead Related Therapy For Non-Ventricular Rhythm	0.31% 6/1930 • Number of events 6 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Related Abnormal Lead Impedance	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Related Lead Insulation Damage	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Lead Related Bilateral Pleural Effusion	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Related Elevated Pacing Thresholds	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Related Lead Externalization	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Lead Related Myopotential Sensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Product Issues RV Lead Related Oversensing	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications RV Lead Related Pectoral Stimulation	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Hematoma/Seroma	1.7% 33/1930 • Number of events 33 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Cardiac/Coronary Sinus Dissection	0.62% 12/1930 • Number of events 12 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations Procedure Related Infection	0.21% 4/1930 • Number of events 4 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Atrial Arrhythmia	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Pericardial Effusion	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Bleeding And/or Hemoptysis	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Cardiac Vein Thrombus	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Part of The Delivery Tool Was Left In The Coronary Sinus/ Ventricle	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Pneumothorax/Hemothorax	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Pulmonary Edema	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Renal Failure or Injury	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Acute Left Arm Thrombophlebitis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Cardiac/Coronary Sinus Perforation	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Decompensated Heart Failure	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Device Incision Erythema	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Excessive Bleeding	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Frozen Shoulder	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related High DFT's	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Hypotension	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Hypotension Requiring Medical Intervention During CRT-D Implant	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Myocardial Infarction	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Procedure Related Pericarditis	0.05% 1/1930 • Number of events 1 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Cardiac disorders Other Therapy For Non-Ventricular Rhythm	0.31% 6/1930 • Number of events 6 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Other Pericardial Effusion	0.16% 3/1930 • Number of events 3 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Injury, poisoning and procedural complications Other Induced Atrial or Ventricular Arrhythmias	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
General disorders Other Pulmonary Edema	0.10% 2/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
Infections and infestations Other Infection	0.05% 1/1930 • Number of events 2 • Complications and observations post implant through 5 years Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)

Additional Information

Clay Cohorn, Clinical Program Director

Abbott

Phone: 972-309-8087

Email: clay.cohorn@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place