Medtronic CRM Product Performance Report

4524 CapSure SP

    Product Characteristics
US Market Release Oct-91   Serial Number Prefix LAR
Registered US Implants 101,700   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 32,300   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 47
Electrical Malfunction 31
Other 8
Number of Leads Enrolled in Study 911
Cumulative Months of Follow-Up 40,567
Number of Leads Active in Study 57
     
Qualifying Complications 6 Total  
Failure to Capture 3  
Failure to Sense 2  
Lead Dislodgement 1  
     

Survival Estimate of 4524 CapSure SP Atrial Placement Leads