• 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	10 yr	at 126 mo
%		99.9	99.7	99.5	99.2	99.2	99.2	98.5	98.5	98.5	98.5	97.6
#		700	499	363	268	227	189	152	128	102	70	47

System Longevity Study Results

Number of Leads Enrolled in Study	1362
Cumulative Months of Follow-Up	40437
Number of Leads Active in Study	65

5

Qualifying Complications

Conductor Fracture	1
Failure to Capture	2
Insulation (not further defined)	1
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	at 123 mo
%		99.6	99.6	99.3	99.3	99.3	99.3	99.3	97.6	97.6	97.6	97.6
#		553	425	322	254	211	160	131	104	78	62	55

System Longevity Study Results

Number of Leads Enrolled in Study	968
Cumulative Months of Follow-Up	34032
Number of Leads Active in Study	31

6

Qualifying Complications

Failure to Capture	2
Impedance Out of Range	1
Insulation (not further defined)	1
Lead Dislodgement	1
Oversensing	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