Medtronic CRM Product Performance Report

3830 SelectSecure

    Product Characteristics
US Market Release Aug-05   Serial Number Prefix LFF
Registered US Implants 12,200   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 10,600   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 21
Electrical Malfunction 5
Other 1
Number of Leads Enrolled in Study 166
Cumulative Months of Follow-Up 5,129
Number of Leads Active in Study 95
     
Qualifying Complications 1 Total  
Failure to Sense 1  
     

Survival Estimate of 3830 SelectSecure Atrial Placement Leads

Ventricular Placement    
System Longevity Study Results    
Number of Leads Enrolled in Study 148
Cumulative Months of Follow-Up 4,983
Number of Leads Active in Study 82
     
Qualifying Complications 0 Total  
     
Survival Estimate of 3830 SelectSecure Ventricular Placement Leads