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 96.0 93.7 92.5 90.5 88.6 88.6 83.9 82.8 78.6 74.6                  
#   807 704 615 511 429 346 283 221 149 107 74 53                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1019
Cumulative Months of Follow-Up 58381
Number of Leads Active in Study 244
Information 93

Qualifying Complications

Conductor Fracture 26
Extra Cardiac Stimulation 2
Failure to Capture 29
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 3
Oversensing 24
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 4
Failure to Capture 52
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 Implants48928
Estimated Active USA Implants30033
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution166650
Information

USA Returned Product Analysis

Conductor Fracture 102
Insulation Breach 52
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 128
Insulation Breach 65
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 November 8, 2019

www.medtronic.com/productperformance 726050