Medtronic CRM Product Performance Report

6961 Tenax

    Product Characteristics
US Market Release Jan-78   Serial Number Prefix TB
Registered US Implants 44,700   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 2,100   Polarity Unipolar
Advisories None   Steroid No

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 103
Electrical Malfunction 27
Other 0
Number of Leads Enrolled in Study 627
Cumulative Months of Follow-Up 42,864
Number of Leads Active in Study 0
     
Qualifying Complications 22 Total  
Extra Cardiac Stimulation 4  
Failure to Capture 8  
Failure to Sense 6  
Insulation (not further defined) 2  
Lead Dislodgement 1  
Oversensing 1  
     

Survival Estimate of 6961 Tenax Ventricular Placement Leads