Medtronic CRM Product Performance Report

4011 Target Tip

    Product Characteristics
US Market Release Nov-82   Serial Number Prefix IB
Registered US Implants 58,400   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 6,200   Polarity Unipolar
Advisories None   Steroid No

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 29
Electrical Malfunction 152
Other 5
Number of Leads Enrolled in Study 851
Cumulative Months of Follow-Up 54,409
Number of Leads Active in Study 2
     
Qualifying Complications 25 Total  
Conductor Fracture 1  
Extra Cardiac Stimulation 4  
Failure to Capture 9  
Insulation (not further defined) 10  
Oversensing 1  
     

Survival Estimate of 4011 Target Tip Ventricular Placement Leads