Medtronic CRM Product Performance Report

4574 CapSure Sense

    Product Characteristics
US Market Release Jun-02   Serial Number Prefix BBE
Registered US Implants 39,900   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 30,300   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 7
Electrical Malfunction 2
Other 0
Number of Leads Enrolled in Study 18
Cumulative Months of Follow-Up 325
Number of Leads Active in Study 16
     
Qualifying Complications 0 Total  
     

Survival Estimate of 4574 CapSure Sense Atrial Placement Leads