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 97.7 96.2 93.9 92.7 90.9 89.1 89.1 84.6 83.4 78.8 77.7                  
#   769 677 593 490 419 336 269 203 138 94 67 58                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1001
Cumulative Months of Follow-Up 55777
Number of Leads Active in Study 257
Information 86

Qualifying Complications

Conductor Fracture 24
Extra Cardiac Stimulation 2
Failure to Capture 27
Failure to Sense 3
Impedance Out of Range 5
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 3
Extra Cardiac Stimulation 2
Failure to Capture 42
Failure to Sense 2
Impedance Out of Range 6
Insulation Breach 1
Lead Dislodgement 6
Oversensing 17
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants45617
Estimated Active USA Implants28010
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution153102
Information

USA Returned Product Analysis

Conductor Fracture 91
Insulation Breach 49
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 112
Insulation Breach 58
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 October 12, 2018

www.medtronic.com/productperformance 626050