4968 CapSure Epi
Epi/Myocardial Pacing
4968 CapSure Epi
ALL
Information

Device Survival Probability


4968_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr                      
% Survival 99.4 97.4 95.6 93.3 91.8 89.9 88.1 87.5 84.0 82.8                      
#   630 542 450 345 286 213 159 112 73 54                      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 829
Cumulative Months of Follow-Up 40201
Number of Leads Active in Study 303
Information 63

Qualifying Complications

Conductor Fracture 14
Extra Cardiac Stimulation 2
Failure to Capture 22
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 3
Oversensing 13
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 1
Failure to Capture 18
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 3
Oversensing 4
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants30568
Estimated Active USA Implants18857
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution97008
Information

USA Returned Product Analysis

Conductor Fracture 38
Insulation Breach 21
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 46
Insulation Breach 26
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 January 31, 2014

www.medtronic.com/productperformance 301050