Medtronic CRM Product Performance Report

4193 Attain

    Product Characteristics
US Market Release May-02   Serial Number Prefix BAA
Registered US Implants 98,100   Type and/or Fixation Transvenous, Left Ventricular Cardiac Vein, Distal Double Curve
Estimated Active US Implants 54,100   Polarity Unipolar
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 65
Electrical Malfunction 23
Other 64
Number of Leads Enrolled in Study 673
Cumulative Months of Follow-Up 22,161
Number of Leads Active in Study 259
   
   
Qualifying Complications 34 Total  
Conductor Fracture 1  
Extra Cardiac Stimulation 6  
Failure to Capture 11  
Lead Dislodgement 13  
Unspecified Clinical Failure 3  

Survival Estimate of 4193 Attain Leads