• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

5076_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	at 222.0 mo
%		99.5	99.3	99.2	99.0	98.8	98.4	98.2	97.9	97.6	97.6	97.3	97.3	96.5	95.5	95.5	95.5	95.5	95.5	95.5
#		2268	1950	1658	1380	1155	917	741	616	533	462	376	284	215	176	142	122	93	72	62

Product Surveillance Registry Results

Number of Leads Enrolled in Study	3433
Cumulative Months of Follow-Up	174388
Number of Leads Active in Study	512

39

Qualifying Complications

Cardiac Perforation	1
Conductor Fracture	10
Failure to Capture	13
Failure to Sense	1
Impedance Out of Range	4
Insulation (not further defined)	1
Lead Dislodgement	5
Oversensing	2
Other	2

ATRIAL PLACEMENT

Device Survival Probability

5076_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	18 yr	19 yr	20 yr
%		99.6	99.4	99.3	99.1	98.8	98.6	98.5	98.3	98.3	98.2	98.2	98.0	97.8	97.3	97.2	97.2	96.7	96.7	96.7	96.7
#		10115	7972	6542	5460	4591	3810	3227	2626	2054	1643	1311	1002	773	603	480	399	313	226	144	77

Product Surveillance Registry Results

Number of Leads Enrolled in Study	14201
Cumulative Months of Follow-Up	704948
Number of Leads Active in Study	4837

128

Qualifying Complications

Cardiac Perforation	2
Conductor Fracture	15
Extra Cardiac Stimulation	3
Failure to Capture	19
Failure to Sense	12
Impedance Out of Range	13
Insulation (not further defined)	3
Lead Dislodgement	49
Oversensing	3
Other	9

Customer Communications For This Model

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Data as of May 24, 2025