• VENTRICULAR PLACEMENT
• ATRIAL PLACEMENT

VENTRICULAR PLACEMENT

Device Survival Probability

5086MRI_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	at 150.0 mo
%		99.7	99.7	99.6	99.6	99.6	99.3	98.3	98.0	98.0	98.0	98.0	97.5	97.5
#		2526	2183	1851	1426	735	423	375	332	300	277	197	104	72

Product Surveillance Registry Results

Number of Leads Enrolled in Study	3073
Cumulative Months of Follow-Up	145681
Number of Leads Active in Study	1237

20

Qualifying Complications

Conductor Fracture	3
Failure to Capture	8
Failure to Sense	1
Impedance Out of Range	2
Lead Dislodgement	3
Oversensing	2
Other	1

ATRIAL PLACEMENT

Device Survival Probability

5086MRI_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	at 150.0 mo
%		99.8	99.6	99.6	99.4	99.3	98.9	98.4	98.4	98.4	98.1	98.1	98.1	98.1
#		2528	2202	1878	1460	766	453	397	354	317	294	211	111	74

Product Surveillance Registry Results

Number of Leads Enrolled in Study	3142
Cumulative Months of Follow-Up	148543
Number of Leads Active in Study	1255

21

Qualifying Complications

Conductor Fracture	3
Failure to Capture	3
Lead Dislodgement	12
Oversensing	2
Other	1

Customer Communications For This Model

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Data as of May 24, 2025