Medtronic CRM Product Performance Report

4558M Screw-In

    Product Characteristics
US Market Release Nov-94   Serial Number Prefix LDC
Registered US Implants 20,000   Type and/or Fixation Transvenous, Atrial-J, Screw-in
Estimated Active US Implants 5,200   Polarity Bipolar
Advisories None   Steroid No

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 1
Crimp/Weld/Bond 1
Insulation Breach 15
Extrinsic 110
Other 1
Number of Leads Enrolled in Study 539
Cumulative Months of Follow-Up 17,935
Number of Leads Active in Study 23
     
Qualifying Complications 12 Total  
Electrical Abandonment 1  
Failure to Capture 3  
Failure to Sense 2  
Impedance Out of Range 2  
Insulation (not further defined) 2  
Oversensing 2  
     

 

Survival Estimate of 4558M Screw-In Atrial Placement Leads