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                      
% Survival 99.4 97.5 96.2 94.0 92.6 90.7 88.9 88.9 85.7 84.5                      
#   661 569 475 366 299 225 170 123 80 57                      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 851
Cumulative Months of Follow-Up 42305
Number of Leads Active in Study 302
Information 60

Qualifying Complications

Conductor Fracture 14
Extra Cardiac Stimulation 2
Failure to Capture 20
Failure to Sense 3
Impedance Out of Range 4
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

Conductor Fracture 2
Extra Cardiac Stimulation 1
Failure to Capture 22
Impedance Out of Range 3
Insulation Breach 1
Lead Dislodgement 3
Oversensing 3
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants32198
Estimated Active USA Implants19935
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution102705
Information

USA Returned Product Analysis

Conductor Fracture 41
Insulation Breach 25
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 50
Insulation Breach 30
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 August 3, 2014

www.medtronic.com/productperformance 326050