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                
% Survival 99.5 97.4 95.9 94.1 93.0 90.6 88.8 88.8 84.0 83.0 79.6 75.5 71.2                
#   803 719 630 536 460 378 321 273 190 147 106 83 55                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1032
Cumulative Months of Follow-Up 62657
Number of Leads Active in Study 204
Information 99

Qualifying Complications

Conductor Fracture 27
Extra Cardiac Stimulation 2
Failure to Capture 30
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 4
Lead Dislodgement 1
Oversensing 25
Other 2
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 6
Failure to Capture 68
Failure to Sense 8
Impedance Out of Range 13
Insulation Breach 1
Lead Dislodgement 7
Oversensing 28
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants54845
Estimated Active USA Implants29632
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution195032
Information

USA Returned Product Analysis

Conductor Fracture 123
Insulation Breach 67
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 156
Insulation Breach 83
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 11, 2021

www.medtronic.com/productperformance 826050