Medtronic CRM Product Performance Report

6940 CapSureFix

    Product Characteristics
US Market Release Oct-98   Serial Number Prefix TCP
Registered US Implants 25,500   Type and/or Fixation Transvenous, A or V, Screw-in
Estimated Active US Implants 9,800   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 9
Crimp/Weld/Bond 0
Insulation Breach 13
Extrinsic 115
Other 4
Number of Leads Enrolled in Study 816
Cumulative Months of Follow-Up 39,504
Number of Leads Active in Study 124
     
Qualifying Complications 11 Total  
Conductor Fracture 1  
Failure to Sense 3  
Lead Dislodgement 1  
Oversensing 6  
     

 

Survival Estimate of 6940 CapSureFix Atrial Placement Leads