Medtronic CRM Product Performance Report

4012 Target Tip

    Product Characteristics
US Market Release Jul-83   Serial Number Prefix HQ
Registered US Implants 93,700   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 6,500   Polarity Bipolar
      Steroid No
Advisories 1   See 1991 Lead Survival Below Expectations

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 50
Electrical Malfunction 827
Other 34
Number of Leads Enrolled in Study 2,543
Cumulative Months of Follow-Up 151,162
Number of Leads Active in Study 10
     
Qualifying Complications 316 Total  
Conductor Fracture 6  
Extra Cardiac Stimulation 3  
Failure to Capture 126  
Failure to Sense 77  
Impedance Out of Range 26  
Insulation (ESC) 9  
Insulation (MIO) 4  
Insulation (not further defined) 16  
Medical Judgment 1  
Oversensing 48  
     

Survival Estimate of 4012 Target Tip Ventricular Placement Leads