• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

4074_VEN_SURV

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		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	14 yr	15 yr	16 yr	17 yr	18 yr
%		99.5	99.3	99.2	99.2	99.2	99.2	99.2	99.2	99.2	98.8	98.8	97.6	97.6	96.9	96.9	96.9	96.9	96.9
#		1031	880	742	638	499	408	344	300	261	223	193	161	130	123	111	92	73	50

Product Surveillance Registry Results

Number of Leads Enrolled in Study	1192
Cumulative Months of Follow-Up	82469
Number of Leads Active in Study	110

12

Qualifying Complications

Conductor Fracture	1
Failure to Capture	4
Impedance Out of Range	2
Insulation (not further defined)	2
Lead Dislodgement	2
Other	1

ATRIAL PLACEMENT

Device Survival Probability

4074_ATR_SURV

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		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	14 yr	15 yr	16 yr	17 yr	at 210.0 mo
%		99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1	99.1
#		214	205	198	183	167	158	148	136	126	117	110	107	99	96	88	77	68	61

Product Surveillance Registry Results

Number of Leads Enrolled in Study	227
Cumulative Months of Follow-Up	30107
Number of Leads Active in Study	45

2

Qualifying Complications

Failure to Sense	1
Lead Dislodgement	1

Customer Communications For This Model

• There are no communications for this model.

Data as of May 24, 2025