Medtronic CRM Product Performance Report

6947 Sprint Quattro Secure

    Product Characteristics
US Market Release Nov-01   Serial Number Prefix TDG
Registered US Implants 206,100   Type and/or Fixation Transvenous, Vent, Defib and
Pace/Sense, Screw-in
Estimated Active US Implants 151,200   Polarity True Bipolar/Two Coils
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 476
Electrical Malfunction 137
Other 25
Number of Leads Enrolled in Study 1,397
Cumulative Months of Follow-Up 54,528
Number of Leads Active in Study 597
     
Qualifying Complications 23 Total  
Conductor Fracture 3  
Failure to Sense 2  
Impedance Out of Range 4  
Insulation (not further defined) 2  
Lead Dislodgement 3  
Oversensing 7  
Unspecified Clinical Failure 2  
     
     
Survival Estimate of Sprint Quattro Lead Model 6947