Medtronic CRM Product Performance Report

6962 Tenax

    Product Characteristics
US Market Release Jan-78   Serial Number Prefix UB
Registered US Implants 70,600   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 3,200   Polarity Bipolar
Advisories None   Steroid No

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 170
Electrical Malfunction 84
Other 0
Number of Leads Enrolled in Study 1,483
Cumulative Months of Follow-Up 109,942
Number of Leads Active in Study 2
     
Qualifying Complications 52 Total  
Conductor Fracture 5  
Extra Cardiac Stimulation 1  
Failure to Capture 27  
Failure to Sense 10  
Impedance Out of Range 3  
Insulation (not further defined) 2  
Lead Dislodgement 1  
Oversensing 3  
     

Survival Estimate of 6962 Tenax Ventricular Placement Leads