Medtronic CRM Product Performance Report

5092 CapSure SP Novus

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LET
Registered US Implants 111,800   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 61,600   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 48
Electrical Malfunction 28
Other 11
Number of Leads Enrolled in Study 1,171
Cumulative Months of Follow-Up 41,628
Number of Leads Active in Study 227
     
Qualifying Complications 8 Total  
Extra Cardiac Stimulation 1  
Failure to Capture 2  
Lead Dislodgement 5  
     

Survival Estimate of 5092 CapSure SP Novus Ventricular Placement Leads