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

Device Survival Probability


4965_SURV
    1 yr 2 yr 3 yr 4 yr            
% Survival 98.6 97.6 96.5 89.9            
#   120 103 81 55            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 226
Cumulative Months of Follow-Up 6388
Number of Leads Active in Study 29
Information 13

Qualifying Complications

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

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 4
Failure to Sense 5
Impedance Out of Range 5
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release1996-09-06
CE Approval Date1993-01-01
Registered USA Implants21405
Estimated Active USA Implants9428
US Market Release1996-09-06
CE Approval Date1993-01-01
Estimated WW Distribution46656
Information

USA Returned Product Analysis

Conductor Fracture 180
Insulation Breach 39
Crimp/Weld/Bond 1
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 224
Insulation Breach 43
Crimp/Weld/Bond 1
Other 3
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 Silicine
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid Yes
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050