Medtronic CRM Product Performance Report

6942 Sprint

    Product Characteristics
US Market Release Jul-97   Serial Number Prefix TCB
Registered US Implants 17,700   Type and/or Fixation Transvenous, Vent, Defib and
Pace/Sense, Tines
Estimated Active US Implants 7,400   Polarity Integrated Bipolar/Two Coils
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 31
Electrical Malfunction 37
Other 5
Number of Leads Enrolled in Study 351
Cumulative Months of Follow-Up 15,650
Number of Leads Active in Study 57
   
Qualifying Complications 7 Total  
Conductor Fracture 1  
Failure to Sense 1  
Lead Dislodgement 1  
Oversensing 3  
Unspecified Clinical Failure 1  
     
Survival Estimate of Sprint 6942