• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	at 78 mo
%		99.8	99.8	99.7	99.7	99.0	99.0	99.0
#		1087	829	534	353	200	76	44

System Longevity Study Results

Number of Leads Enrolled in Study	1229
Cumulative Months of Follow-Up	46434
Number of Leads Active in Study	744

5

Qualifying Complications

Extra Cardiac Stimulation	1
Failure to Capture	3
Impedance Out of Range	1

ATRIAL PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	6 yr	at 75 mo
%		99.8	99.6	99.5	99.5	99.5	98.9	98.9
#		1471	1112	642	370	208	68	48

System Longevity Study Results

Number of Leads Enrolled in Study	1662
Cumulative Months of Follow-Up	59076
Number of Leads Active in Study	1017

8

Qualifying Complications

Conductor Fracture	1
Failure to Capture	2
Failure to Sense	1
Insulation (not further defined)	1
Lead Dislodgement	3

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