Medtronic CRM Product Performance Report

4023 CapSure SP

    Product Characteristics
US Market Release Aug-91   Serial Number Prefix LAK
Registered US Implants 41,200   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 9,600   Polarity Unipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 47
Electrical Malfunction 21
Other 6
Number of Leads Enrolled in Study 1,158
Cumulative Months of Follow-Up 65,853
Number of Leads Active in Study 341
     
Qualifying Complications 20 Total  
Extra Cardiac Stimulation 1  
Failure to Capture 15  
Impedance Out of Range 1  
Insulation (not further defined) 1  
Lead Dislodgement 2  

Survival Estimate of 4023 CapSure SP Ventricular Placement Leads