Medtronic CRM Product Performance Report

5554 CapSure Z Novus

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LEJ
Registered US Implants 54,800   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 31,500   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 8
Electrical Malfunction 12
Other 4
Number of Leads Enrolled in Study 338
Cumulative Months of Follow-Up 18,883
Number of Leads Active in Study 60
     
Qualifying Complications 4 Total  
Failure to Capture 1  
Impedance Out of Range 1  
Lead Dislodgement 1  
Oversensing 1  
     

Survival Estimate of 5554 CapSure Z Novus Atrial Placement Leads