Medtronic CRM Product Performance Report

5054 CapSure Z Novus

    Product Characteristics
US Market Release Jun-98   Serial Number Prefix LEH
Registered US Implants 85,400   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 44,900   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 43
Electrical Malfunction 16
Other 6
Number of Leads Enrolled in Study 1,392
Cumulative Months of Follow-Up 63,013
Number of Leads Active in Study 463
     
Qualifying Complications 11 Total  
Failure to Capture 7  
Failure to Sense 1  
Impedance Out of Range 1  
Lead Dislodgement 2  
     

Survival Estimate of 5054 CapSure Z Novus Ventricular Placement Leads