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 96.3 94.4 93.3 91.5 89.5 89.5 84.3 82.9 78.7 77.5                  
#   752 656 554 459 374 293 234 178 121 80 59 52                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 972
Cumulative Months of Follow-Up 51758
Number of Leads Active in Study 276
Information 78

Qualifying Complications

Conductor Fracture 20
Extra Cardiac Stimulation 2
Failure to Capture 27
Failure to Sense 3
Impedance Out of Range 4
Insulation (not further defined) 3
Oversensing 18
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 38
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 Implants42587
Estimated Active USA Implants26028
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution142054
Information

USA Returned Product Analysis

Conductor Fracture 81
Insulation Breach 45
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 96
Insulation Breach 53
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 July 31, 2017

www.medtronic.com/productperformance 501050