Medtronic CRM Product Performance Report

4067 CapSureFix

    Product Characteristics
US Market Release Jan-97   Serial Number Prefix LCV
Registered US Implants 1,000   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 300   Polarity Unipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 3
Electrical Malfunction 1
Other 1
Number of Leads Enrolled in Study 109
Cumulative Months of Follow-Up 6,490
Number of Leads Active in Study 39
     
Qualifying Complications 6 Total  
Failure to Capture 5  
Oversensing 1  

Survival Estimate of 4067 CapSureFix Atrial Placement Leads