Medtronic CRM Product Performance Report

4057, 4057M Screw-In

    Product Characteristics
US Market Release Aug-88   Serial Number Prefix XQ or LAN
Registered US Implants 10,100   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 1,800   Polarity Unipolar
Advisories None   Steroid No

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 39
Electrical Malfunction 6
Other 4
Number of Leads Enrolled in Study 259
Cumulative Months of Follow-Up 15,351
Number of Leads Active in Study 9
     
Qualifying Complications 7 Total  
Conductor Fracture 2  
Extra Cardiac Stimulation 2  
Failure to Capture 2  
Failure to Sense 1  
     

Survival Estimate of 4057, 4057M Screw-In Ventricular Placement Leads