Medtronic CRM Product Performance Report

6933, 6937, 6937A, 6963 SVC/CS

  Product Characteristics
US Market Release Dec-93   Serial Number Prefix TAT, TBU, or TAF
Registered US Implants 16,800   Type and/or Fixation Transvenous CS or SVC Defib
Estimated Active US Implants 2,600   Polarity One Defib Coil
Advisories None   Steroid No

 

System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 166
Crimp/Weld/Bond 0
Insulation Breach 32
Extrinsic 31
Other 16
Number of Leads Enrolled in Study 966
Cumulative Months of Follow-Up 49,684
Number of Leads Active in Study 34
   
Qualifying Complications 54 Total  
Conductor Fracture 17  
Extra Cardiac Stimulation 5  
Failure to Capture 8  
Failure to Sense 1  
Impedance out of Range 4  
Lead Dislodgement 1  
Insulation (not further defined) 2  
Oversensing 12  
Unspecified Clinical Failure 4  

 

Survival Estimate of 6933, 6937, 6937A, 6963 SVC/CS