4968 CapSure Epi
Epi/Myocardial Pacing
4968 CapSure Epi
ALL
Information

Device Survival Probability

4968_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                  
% Survival 99.5 97.5 96.1 94.2 93.0 90.9 89.0 89.0 84.5 83.5 79.6 74.9                  
#   819 718 632 521 440 358 297 231 161 113 82 61                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1023
Cumulative Months of Follow-Up 60089
Number of Leads Active in Study 226
Information 93

Qualifying Complications

Conductor Fracture 24
Extra Cardiac Stimulation 2
Failure to Capture 29
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 3
Lead Dislodgement 1
Oversensing 24
Other 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 4
Failure to Capture 57
Failure to Sense 5
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 6
Oversensing 21
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants50106
Estimated Active USA Implants30442
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution171569
Information

USA Returned Product Analysis

Conductor Fracture 104
Insulation Breach 54
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 131
Insulation Breach 67
Crimp/Weld/Bond 0
Other 1
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 Bipolar
More
Serial Number Prefix LEN
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of April 10, 2020

www.medtronic.com/productperformance 751050