4965 CapSure Epi
Epi/Myocardial Pacing
4965 CapSure Epi
ALL
Information

Device Survival Probability

4965_SURV
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    1 yr 2 yr 3 yr 4 yr at 54.0 mo          
% Survival 98.6 96.8 95.7 87.2 82.5          
#   132 113 93 68 50          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 233
Cumulative Months of Follow-Up 7305
Number of Leads Active in Study 6
Information 16

Qualifying Complications

Conductor Fracture 9
Failure to Capture 3
Failure to Sense 1
Impedance Out of Range 0
Insulation (not further defined) 1
Oversensing 2
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Failure to Capture 10
Failure to Sense 5
Impedance Out of Range 16
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release1996-09-06
CE Approval Date1993-01-01
Registered USA Implants23252
Estimated Active USA Implants8363
US Market Release1996-09-06
CE Approval Date1993-01-01
Estimated WW Distribution56624
Information

USA Returned Product Analysis

Conductor Fracture 276
Insulation Breach 62
Crimp/Weld/Bond 1
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 333
Insulation Breach 70
Crimp/Weld/Bond 1
Other 0
Information

Product Characteristics

Lead Type Epi/Myocardial
Type and/or Fixation Suture
Lead Function Pacing/Sensing
Lead Placement Myocardial
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Unipolar
More
Serial Number Prefix LBT
Lead Body Diameter 4.5 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid Yes
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050