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

Device Survival Probability

4968_SURV
Loading...











    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 94.0 92.6 90.8 89.2 89.2 86.1 84.9 84.9                    
#   679 588 501 382 305 234 181 131 82 59 50                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 864
Cumulative Months of Follow-Up 43771
Number of Leads Active in Study 297
Information 61

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 2
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
Failure to Sense 1
Impedance Out of Range 3
Insulation Breach 1
Lead Dislodgement 4
Oversensing 4
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants33661
Estimated Active USA Implants20822
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution107695
Information

USA Returned Product Analysis

Conductor Fracture 46
Insulation Breach 28
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 55
Insulation Breach 34
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
Hide this content

Data as of February 9, 2015

www.medtronic.com/productperformance 351052