Medtronic CRM Product Performance Report

4592 CapSure SP Novus

    Product Characteristics
US Market Release Oct-98   Serial Number Prefix LER
Registered US Implants 74,400   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 43,500   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 13
Electrical Malfunction 5
Other 0
Number of Leads Enrolled in Study 244
Cumulative Months of Follow-Up 11,373
Number of Leads Active in Study 84
     
Qualifying Complications 5 Total  
Failure to Capture 2  
Failure to Sense 1  
Lead Dislodgement 2  
     

Survival Estimate of 4592 CapSure SP Novus Atrial Placement Leads