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 at 126.0 mo                    
% Survival 99.5 97.6 96.1 94.1 92.8 91.1 89.5 89.5 86.6 84.6 84.6                    
#   686 602 510 396 317 240 188 143 86 61 52                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 887
Cumulative Months of Follow-Up 45079
Number of Leads Active in Study 293
Information 63

Qualifying Complications

Conductor Fracture 15
Extra Cardiac Stimulation 2
Failure to Capture 20
Failure to Sense 3
Impedance Out of Range 4
Insulation (not further defined) 3
Oversensing 14
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 1
Failure to Capture 23
Failure to Sense 1
Impedance Out of Range 4
Insulation Breach 1
Lead Dislodgement 5
Oversensing 9
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants36185
Estimated Active USA Implants21813
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution119776
Information

USA Returned Product Analysis

Conductor Fracture 51
Insulation Breach 32
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 60
Insulation Breach 38
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 2, 2015

www.medtronic.com/productperformance 376051