Medtronic CRM Product Performance Report

3830 SelectSecure

    Product Characteristics
US Market Release Aug-05   Serial Number Prefix LFF
Registered US Implants 14,000   Type and/or Fixation Transvenous, V or A, Screw-in
Estimated Active US Implants 12,100   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 22
Other 2
Number of Leads Enrolled in Study 198
Cumulative Months of Follow-Up 6,707
Number of Leads Active in Study 122
     
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 167
Cumulative Months of Follow-Up 6,399
Number of Leads Active in Study 95
     
Qualifying Complications 0 Total  
     

 

Survival Estimate of 3830 SelectSecure Ventricular Placement Leads