Medtronic CRM Product Performance Report

4092 CapSure SP Novus

    Product Characteristics
US Market Release Sep-98   Serial Number Prefix LEP
Registered US Implants 151,000   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 83,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 39
Electrical Malfunction 19
Other 5
Number of Leads Enrolled in Study 1,145
Cumulative Months of Follow-Up 55,839
Number of Leads Active in Study 512
     
Qualifying Complications 17 Total  
Conductor Fracture 3  
Extra Cardiac Stimulation 1  
Failure to Capture 8  
Impedance Out of Range 1  
Lead Dislodgement 4  
     

Survival Estimate of 4092 CapSure SP Novus Ventricular Placement Leads