4965 CapSure Epi
Epi/Myocardial Pacing
4965 CapSure Epi

Device Survival Probability


    1 yr 2 yr 3 yr 4 yr            
% Survival 98.6 97.7 96.6 90.1            
#   129 110 86 64            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 231
Cumulative Months of Follow-Up 6973
Number of Leads Active in Study 7
Information 13

Qualifying Complications

Conductor Fracture 6
Failure to Capture 3
Failure to Sense 1
Insulation (not further defined) 1
Oversensing 2

Advisories For This Model

  • There are no advisories for this model.

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 5
Failure to Sense 5
Impedance Out of Range 6
Oversensing 1
Unspecified Clinical Failure 3

Distribution Data

US Market Release1996-09-06
CE Approval Date1993-01-01
Registered USA Implants22393
Estimated Active USA Implants8778
US Market Release1996-09-06
CE Approval Date1993-01-01
Estimated WW Distribution51727

USA Returned Product Analysis

Conductor Fracture 218
Insulation Breach 43
Crimp/Weld/Bond 1
Other 0

WW Returned Product Analysis

Conductor Fracture 266
Insulation Breach 47
Crimp/Weld/Bond 1
Other 3

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
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 April 14, 2016

www.medtronic.com/productperformance 426050