Medtronic CRM Product Performance Report

4076 CapSureFix Novus

    Product Characteristics
US Market Release Feb-04   Serial Number Prefix BBL
Registered US Implants 199,200   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 165,500   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 96
Electrical Malfunction 13
Other 8
Number of Leads Enrolled in Study 745
Cumulative Months of Follow-Up 17,688
Number of Leads Active in Study 618
     
Qualifying Complications 3 Total  
Failure to Capture 1  
Lead Dislodgement 2  

Survival Estimate of 4076 CapSureFix Novus Atrial Placement Leads

 

Ventricular Placement    
System Longevity Study Results    
Number of Leads Enrolled in Study 668
Cumulative Months of Follow-Up 17,812
Number of Leads Active in Study 555
     
Qualifying Complications 2 Total  
Failure to Capture 2  
     
Survival Estimate of 4076 CapSureFix Novus Ventricular Placement Leads