Medtronic CRM Product Performance Report

5092 CapSure SP Novus

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LET
Registered US Implants 115,400   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 62,800   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 4
Crimp/Weld/Bond 0
Insulation Breach 27
Extrinsic 50
Other 12
Number of Leads Enrolled in Study 1,171
Cumulative Months of Follow-Up 43,070
Number of Leads Active in Study 206
     
Qualifying Complications 7 Total  
Extra Cardiac Stimulation 1  
Failure to Capture 1  
Lead Dislodgement 5  
     

 

Survival Estimate of 5092 CapSure SP Novus Ventricular Placement Leads