• 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
%		99.7	99.4	99.1	98.8	98.8	98.8	98.1	96.6
#		886	671	507	340	211	127	77	50

System Longevity Study Results

Number of Leads Enrolled in Study	1209
Cumulative Months of Follow-Up	44496
Number of Leads Active in Study	12

11

Qualifying Complications

Conductor Fracture	1
Failure to Capture	7
Failure to Sense	2
Lead Dislodgement	1

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	11 yr	12 yr	13 yr	at 159 mo
%		99.5	99.5	99.5	99.5	99.5	99.5	98.8	98.8	98.8	98.8	98.8	98.8	97.5	97.5
#		383	382	379	373	355	330	294	250	207	183	147	102	61	50

System Longevity Study Results

Number of Leads Enrolled in Study	386
Cumulative Months of Follow-Up	44637
Number of Leads Active in Study	130

5

Qualifying Complications

Conductor Fracture	1
Failure to Capture	2
Failure to Sense	1
Impedance Out of Range	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