• 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	19 yr
%		99.5	99.3	99.2	98.9	98.8	98.4	98.2	97.9	97.5	97.5	97.3	97.3	96.5	95.5	95.5	95.5	95.5	95.5	95.5
#		2278	1965	1675	1410	1182	953	758	628	540	470	391	301	220	179	148	125	98	75	52

Product Surveillance Registry Results

Number of Leads Enrolled in Study	3434
Cumulative Months of Follow-Up	177514
Number of Leads Active in Study	440

41

Qualifying Complications

Cardiac Perforation	1
Conductor Fracture	10
Failure to Capture	13
Failure to Sense	1
Impedance Out of Range	6
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
%		99.5	99.4	99.3	99.1	98.8	98.6	98.5	98.3	98.2	98.1	98.1	97.9	97.7	97.3	97.1	97.1	96.6	96.6	96.6	96.6
#		10552	8395	6854	5660	4768	3949	3314	2760	2167	1716	1396	1061	797	626	508	416	331	254	167	87

Product Surveillance Registry Results

Number of Leads Enrolled in Study	14209
Cumulative Months of Follow-Up	735050
Number of Leads Active in Study	4549

136

Qualifying Complications

Cardiac Perforation	2
Conductor Fracture	16
Extra Cardiac Stimulation	3
Failure to Capture	21
Failure to Sense	13
Impedance Out of Range	13
Insulation (not further defined)	3
Lead Dislodgement	51
Oversensing	4
Other	10

Customer Communications For This Model

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Data as of December 1, 2025