Medtronic CRM Product Performance Report

4557, 4557M Screw-In

    Product Characteristics
US Market Release Aug-88   Serial Number Prefix VQ or LAM
Registered US Implants 19,700   Type and/or Fixation Transvenous, Atrial-J, Screw-in
Estimated Active US Implants 4,400   Polarity Unipolar
Advisories None   Steroid No

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 53
Electrical Malfunction 14
Other 4
Number of Leads Enrolled in Study 294
Cumulative Months of Follow-Up 18,465
Number of Leads Active in Study 10
     
Qualifying Complications 6 Total  
Extra Cardiac Stimulation 1  
Failure to Capture 3  
Failure to Sense 1  
Oversensing 1  
     

Survival Estimate of 4557, 4557M Screw-In Atrial Placement Leads