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 10,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 114
Electrical Malfunction 21
Other 3
Number of Leads Enrolled in Study 818
Cumulative Months of Follow-Up 38,362
Number of Leads Active in Study 151
     
Qualifying Complications 7 Total  
Conductor Fracture 1  
Failure to Sense 2  
Lead Dislodgement 1  
Oversensing 3  
     

Survival Estimate of 6940 CapSureFix Atrial Placement Leads