4965 CapSure Epi
Epi/Myocardial Pacing
4965 CapSure Epi

Device Survival Probability


    1 yr 2 yr 3 yr 4 yr            
% Survival 98.6 97.6 96.5 90.0            
#   125 104 84 61            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 228
Cumulative Months of Follow-Up 6718
Number of Leads Active in Study 11
Information 13

Qualifying Complications

Conductor Fracture 6
Failure to Capture 3
Failure to Sense 1
Impedance Out of Range 0
Insulation (not further defined) 1
Oversensing 2
Other 0

Advisories For This Model

  • There are no advisories for this model.

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 4
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 Implants21855
Estimated Active USA Implants9290
US Market Release1996-09-06
CE Approval Date1993-01-01
Estimated WW Distribution48380

USA Returned Product Analysis

Conductor Fracture 199
Insulation Breach 41
Crimp/Weld/Bond 1
Other 0

WW Returned Product Analysis

Conductor Fracture 247
Insulation Breach 46
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 September 16, 2015

www.medtronic.com/productperformance 351052