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 13 yr 14 yr              
% Survival 99.4 97.5 96.0 94.3 93.1 91.0 89.4 89.1 84.8 83.6 80.3 77.0 73.7 70.3              
#   821 736 657 566 502 424 366 302 222 180 138 103 71 54              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1050
Cumulative Months of Follow-Up 68092
Number of Leads Active in Study 176
Information 104

Qualifying Complications

Conductor Fracture 31
Extra Cardiac Stimulation 2
Failure to Capture 29
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 4
Lead Dislodgement 1
Oversensing 26
Other 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 4
Extra Cardiac Stimulation 7
Failure to Capture 88
Failure to Sense 11
Impedance Out of Range 21
Insulation Breach 1
Lead Dislodgement 8
Oversensing 31
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants61419
Estimated Active USA Implants33596
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution220333
Information

USA Returned Product Analysis

Conductor Fracture 141
Insulation Breach 79
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 176
Insulation Breach 100
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 December 1, 2023

www.medtronic.com/productperformance 951051