Medtronic CRM Product Performance Report

6947 Sprint Quattro Secure

    Product Characteristics
US Market Release Nov-01   Serial Number Prefix TDG
Estimated US Implants 176,700   Type and/or Fixation Transvenous, Vent, Defib and
Pace/Sense, Screw-in
Estimated US Active 116,400   Polarity True Bipolar/Two Coils
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 344
Electrical Malfunction 117
Other 13
Number of Leads Enrolled in Study 1,367
Cumulative Months of Follow-Up 51,903
Number of Leads Active in Study 622
     
Qualifying Complications 19 Total  
Conductor Fracture 3  
Failure to Sense 1  
Impedance Out of Range 2  
Insulation (not further defined) 1  
Lead Dislodgement 3  
Oversensing 7  
Unspecified Clinical Failure 2  
     
     
Survival Estimate of Sprint Quattro Lead Model 6947