Medtronic CRM Product Performance Report

4568 CapSure Fix

    Product Characteristics
US Market Release Jan-97   Serial Number Prefix LDD
Registered US Implants 69,700   Type and/or Fixation Transvenous, Atrial-J, Screw-in
Estimated Active US Implants 31,700   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 198
Electrical Malfunction 18
Other 4
Number of Leads Enrolled in Study 587
Cumulative Months of Follow-Up 24,835
Number of Leads Active in Study 213
     
Qualifying Complications 33 Total  
Failure to Capture 18  
Failure to Sense 3  
Impedance Out of Range 2  
Lead Dislodgement 9  
Medical Judgment 1  
     

Survival Estimate of 4568 CapSure Fix Atrial Placement Leads