• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	7 yr	8 yr	9 yr	at 117 mo
%		99.6	99.4	99.3	99.0	99.0	98.8	98.8	98.8	98.0	98.0
#		1082	901	744	612	492	394	280	178	90	51

System Longevity Study Results

Number of Leads Enrolled in Study	1539
Cumulative Months of Follow-Up	67711
Number of Leads Active in Study	276

12

Qualifying Complications

Cardiac Perforation	1
Conductor Fracture	1
Failure to Capture	5
Failure to Sense	1
Impedance Out of Range	2
Lead Dislodgement	2

ATRIAL PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	7 yr	8 yr	9 yr	10 yr	at 123 mo
%		99.6	99.6	99.3	99.0	98.8	98.6	98.6	98.5	98.5	97.8	97.8
#		2084	1784	1527	1314	1112	902	624	391	215	82	53

System Longevity Study Results

Number of Leads Enrolled in Study	2744
Cumulative Months of Follow-Up	139060
Number of Leads Active in Study	648

26

Qualifying Complications

Cardiac Perforation	1
Conductor Fracture	2
Extra Cardiac Stimulation	2
Failure to Capture	6
Failure to Sense	2
Impedance Out of Range	4
Insulation (not further defined)	1
Lead Dislodgement	5
Oversensing	2
Unspecified Clinical Failure	1

Advisories For This Model

• There are no advisories for this model.

Performance Notes For This Model

• Tests and Observations for Clinical Assessment of Chronic Pacing Leads