Medtronic CRM Product Performance Report

5594 CapSure SP Novus

    Product Characteristics
US Market Release Jun-01   Serial Number Prefix LFD
Registered US Implants 11,700   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 8,600   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 2
Crimp/Weld/Bond 0
Insulation Breach 2
Extrinsic 1
Other 0
Number of Leads Enrolled in Study 20
Cumulative Months of Follow-Up 1,265
Number of Leads Active in Study 13
     
Qualifying Complications 0 Total  
     

 

Survival Estimate of 5594 CapSure SP Novus Atrial Placement Leads