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 at 138.0 mo                  
% Survival 99.5 97.6 96.4 94.0 92.8 90.9 89.1 89.1 84.4 83.2 78.5 77.3                  
#   763 669 579 488 414 322 259 199 137 96 63 54                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 990
Cumulative Months of Follow-Up 54706
Number of Leads Active in Study 261
Information 84

Qualifying Complications

Conductor Fracture 23
Extra Cardiac Stimulation 2
Failure to Capture 27
Failure to Sense 3
Impedance Out of Range 4
Insulation (not further defined) 3
Oversensing 21
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 2
Failure to Capture 40
Failure to Sense 2
Impedance Out of Range 5
Insulation Breach 1
Lead Dislodgement 6
Oversensing 14
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants44028
Estimated Active USA Implants27021
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution147293
Information

USA Returned Product Analysis

Conductor Fracture 87
Insulation Breach 47
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 103
Insulation Breach 56
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 January 31, 2018

www.medtronic.com/productperformance 601051