• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	at 69 mo
%		99.5	99.5	99.5	99.5	99.5	99.5
#		388	229	142	90	63	49

System Longevity Study Results

Number of Leads Enrolled in Study	475
Cumulative Months of Follow-Up	15455
Number of Leads Active in Study	290

3

Qualifying Complications

Impedance Out of Range	1
Lead Dislodgement	2

ATRIAL PLACEMENT

Device Survival Probability

		1 yr	2 yr	3 yr	4 yr	5 yr	at 63 mo
%		99.2	99.2	99.2	99.2	99.2	99.2
#		612	337	173	98	63	54

System Longevity Study Results

Number of Leads Enrolled in Study	769
Cumulative Months of Follow-Up	22098
Number of Leads Active in Study	509

6

Qualifying Complications

Cardiac Perforation	1
Extra Cardiac Stimulation	1
Failure to Capture	1
Failure to Sense	1
Lead Dislodgement	2

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