Medtronic CRM Product Performance Report

5568 CapSureFix

    Product Characteristics
US Market Release Jan-97   Serial Number Prefix LDN
Registered US Implants 70,400   Type and/or Fixation Transvenous, Atrial-J, Screw-in
Estimated Active US Implants 45,000   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 264
Electrical Malfunction 15
Other 12
Number of Leads Enrolled in Study 920
Cumulative Months of Follow-Up 30,230
Number of Leads Active in Study 184
     
Qualifying Complications 4 Total  
Failure to Capture 2  
Failure to Sense 1  
Lead Dislodgement 1  
     

Survival Estimate of 5568 CapSureFix Atrial Placement Leads