Medtronic CRM Product Performance Report

5072 SureFix

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LEM
Regiestered US Implants 8,900   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 4,500   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 28
Electrical Malfunction 5
Other 1
Number of Leads Enrolled in Study 451
Cumulative Months of Follow-Up 21,911
Number of Leads Active in Study 114
     
Qualifying Complications 2 Total  
Cardiac Perforation 1  
Failure to Capture 1  
     

Survival Estimate of 5072 SureFix Atrial Placement Leads