Medtronic CRM Product Performance Report

5592 CapSure SP Novus

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LEU
Registered US Implants 27,800   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 18,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 6
Electrical Malfunction 3
Other 0
Number of Leads Enrolled in Study 666
Cumulative Months of Follow-Up 26,129
Number of Leads Active in Study 179
     
Qualifying Complications 4 Total  
Failure to Capture 2  
Lead Dislodgement 2  
     

Survival Estimate of 5592 CapSure SP Novus Atrial Placement Leads