Medtronic CRM Product Performance Report

4503, 4503M CapSure

    Product Characteristics
US Market Release Jul-86   Serial Number Prefix MQ, LAY
Registered US Implants 8,000   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 1,500   Polarity Unipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 2
Electrical Malfunction 12
Other 0
Number of Leads Enrolled in Study 59
Cumulative Months of Follow-Up 3,278
Number of Leads Active in Study 6
     
Qualifying Complications 1 Total
Failure to Sense 1  
     
Survival Estimate of 4503, 4503M CapSure Atrial Placement Leads