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 97.5 96.1 94.2 93.0 91.0 88.8 88.8 82.7 81.0 81.0                    
#   704 619 536 431 352 262 205 161 98 67 57                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 903
Cumulative Months of Follow-Up 47838
Number of Leads Active in Study 288
Information 74

Qualifying Complications

Conductor Fracture 18
Extra Cardiac Stimulation 2
Failure to Capture 25
Failure to Sense 3
Impedance Out of Range 4
Insulation (not further defined) 3
Oversensing 17
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 27
Failure to Sense 1
Impedance Out of Range 5
Insulation Breach 1
Lead Dislodgement 5
Oversensing 12
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants37538
Estimated Active USA Implants22636
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution124795
Information

USA Returned Product Analysis

Conductor Fracture 56
Insulation Breach 37
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 67
Insulation Breach 43
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 April 14, 2016

www.medtronic.com/productperformance 426050