• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT
• ALL

VENTRICULAR PLACEMENT

Device Survival Probability

		1 yr	at 21 mo
%		99.8	99.8
#		770	93

Product Surveillance Registry Results

Number of Leads Enrolled in Study	2518
Cumulative Months of Follow-Up	25436
Number of Leads Active in Study	2206

4

Qualifying Complications

Failure to Capture	2
Failure to Sense	1
Lead Dislodgement	1

ATRIAL PLACEMENT

Device Survival Probability

		1 yr	at 21 mo
%		99.9	99.9
#		774	94

Product Surveillance Registry Results

Number of Leads Enrolled in Study	2532
Cumulative Months of Follow-Up	25622
Number of Leads Active in Study	2216

2

Qualifying Complications

Lead Dislodgement	2

ALL

Device Survival Probability

		at 0 mo

Product Surveillance Registry Results

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

Qualifying Complications

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