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 11 yr 12 yr                  
% Survival 99.5 97.6 96.1 93.8 92.6 90.6 88.9 88.9 84.0 82.9 78.6 74.3                  
#   791 702 605 501 425 343 275 218 143 104 74 50                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1015
Cumulative Months of Follow-Up 57407
Number of Leads Active in Study 248
Information 91

Qualifying Complications

Conductor Fracture 25
Extra Cardiac Stimulation 2
Failure to Capture 28
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 3
Oversensing 24
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 3
Failure to Capture 46
Failure to Sense 3
Impedance Out of Range 7
Insulation Breach 1
Lead Dislodgement 6
Oversensing 18
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants47263
Estimated Active USA Implants29121
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution159187
Information

USA Returned Product Analysis

Conductor Fracture 97
Insulation Breach 51
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 120
Insulation Breach 62
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 11, 2019

www.medtronic.com/productperformance 651050