Medtronic CRM Product Performance Report

4523 CapSure SP

    Product Characteristics
US Market Release Aug-91   Serial Number Prefix ZE
Registered US Implants 11,200   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 3,100   Polarity Unipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 1
Crimp/Weld/Bond 0
Insulation Breach 1
Extrinsic 5
Other 1
Number of Leads Enrolled in Study 121
Cumulative Months of Follow-Up 6,607
Number of Leads Active in Study 13
     
Qualifying Complications 4 Total  
Impedance Out of Range 1  
Lead Dislodgement 2  
Oversensing 1  
     

 

Survival Estimate of 4523 CapSure SP Atrial Placement Leads