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 at 150.0 mo                
% Survival 99.5 97.6 96.1 94.3 93.2 91.0 89.1 89.1 84.5 83.5 79.9 75.4 72.0                
#   799 716 619 529 452 367 316 266 186 138 100 74 61                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1027
Cumulative Months of Follow-Up 61494
Number of Leads Active in Study 221
Information 95

Qualifying Complications

Conductor Fracture 24
Extra Cardiac Stimulation 2
Failure to Capture 29
Failure to Sense 3
Impedance Out of Range 5
Insulation (not further defined) 4
Lead Dislodgement 1
Oversensing 25
Other 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 4
Failure to Capture 62
Failure to Sense 7
Impedance Out of Range 10
Insulation Breach 1
Lead Dislodgement 7
Oversensing 24
Information

Distribution Data

US Market Release1999-09-16
CE Approval Date1998-04-21
Registered USA Implants51723
Estimated Active USA Implants31246
US Market Release1999-09-16
CE Approval Date1998-04-21
Estimated WW Distribution177233
Information

USA Returned Product Analysis

Conductor Fracture 109
Insulation Breach 56
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 137
Insulation Breach 69
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 October 29, 2020

www.medtronic.com/productperformance 776050