Medtronic CRM Product Performance Report

5594 CapSure SP Novus

    Product Characteristics
US Market Release Jun-01   Serial Number Prefix LFD
Registered US Implants 10,900   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 8,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 0
Electrical Malfunction 4
Other 0
Number of Leads Enrolled in Study 18
Cumulative Months of Follow-Up 1,068
Number of Leads Active in Study 12
     
Qualifying Complications 0 Total  
     

Survival Estimate of 5594 CapSure SP Novus Atrial Placement Leads