Medtronic CRM Product Performance Report

6917, 6917A Tenax

    Product Characteristics
US Market Release Jun-73   Serial Number Prefix WV or WC
Registered US Implants 180,100   Type and/or Fixation Myocardial Screw-in Vent.
Estimated Active US Implants 5,000   Polarity Unipolar
Advisories None   Steroid No

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 115
Electrical Malfunction 42
Other 1
Number of Leads Enrolled in Study 985
Cumulative Months of Follow-Up 47,481
Number of Leads Active in Study 4
     
Qualifying Complications 69 Total  
Conductor Fracture 6  
Extra Cardiac Stimulation 1  
Failure to Capture 30  
Failure to Sense 11  
Impedance Out of Range 2  
Insulation (MIO) 1  
Oversensing 18  
     

Survival Estimate of 6917, 6917A Tenax Leads