• 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	11 yr	12 yr	at 147 mo
%		99.3	98.7	98.7	98.2	97.8	97.2	95.8	95.0	93.5	93.1	92.4	89.7	89.7
#		1427	1219	1032	832	685	539	405	300	213	133	77	52	49

System Longevity Study Results

Number of Leads Enrolled in Study	1799
Cumulative Months of Follow-Up	95888
Number of Leads Active in Study	162

51

Qualifying Complications

Conductor Fracture	3
Extra Cardiac Stimulation	2
Failure to Capture	22
Failure to Sense	3
Impedance Out of Range	11
Insulation (not further defined)	1
Oversensing	7
Unspecified Clinical Failure	2

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 165 mo
%		98.9	98.7	98.2	98.0	97.4	97.2	96.7	95.3	94.6	93.7	92.5	91.4	89.9	86.2
#		1907	1637	1370	1116	897	737	577	472	358	256	189	135	84	43

System Longevity Study Results

Number of Leads Enrolled in Study	2413
Cumulative Months of Follow-Up	133591
Number of Leads Active in Study	266

77

Qualifying Complications

Conductor Fracture	3
Extra Cardiac Stimulation	2
Failure to Capture	22
Failure to Sense	13
Impedance Out of Range	9
Insulation (ESC)	2
Insulation (MIO)	2
Insulation (not further defined)	2
Lead Dislodgement	8
Oversensing	11
Unspecified Clinical Failure	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