Medtronic CRM Product Performance Report

6948 Sprint Fidelis

    Product Characteristics
US Market Release Sep-04   Serial Number Prefix LFH
Registered US Implants 10,400   Type and/or Fixation Transvenous, Vent, Defib and Pace/
Sense, Tines
Estimated Active US Implants 7,900   Polarity True Bipolar/Two Coils
      Steroid Yes
Advisories 1 2007 Potential Conductor Wire Fracture

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 9
Electrical Malfunction 17
Other 4
Number of Leads Enrolled in Study 30
Cumulative Months of Follow-Up 797
Number of Leads Active in Study 26
     
Qualifying Complications 0 Total  
     
Survival Estimate of Sprint Fidelis Model 6948