Medtronic CRM Product Performance Report

4965 CapSure Epi

    Product Characteristics
US Market Release Sep-96   Serial Number Prefix LBT
Registered US Implants 17,700   Type and/or Fixation Epicardial Suture-On V or A
Estimated Active US Implants 8,900   Polarity Unipolar
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 8
Electrical Malfunction 115
Other 2
Number of Leads Enrolled in Study 188
Cumulative Months of Follow-Up 5,451
Number of Leads Active in Study 28
     
Qualifying Complications 8 Total  
Conductor Fracture 3  
Failure to Capture 2  
Failure to Sense 1  
Oversensing 2  
     

Survival Estimate of 4965 CapSure Epi Leads