Medtronic CRM Product Performance Report

5534 CapSure Z

    Product Characteristics
US Market Release Feb-96   Serial Number Prefix LDG
Registered US Implants 26,300   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 9,300   Polarity Bipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 29
Electrical Malfunction 8
Other 5
Number of Leads Enrolled in Study 261
Cumulative Months of Follow-Up 12,779
Number of Leads Active in Study 23
     
Qualifying Complications 6 Total  
Failure to Capture 5  
Impedance Out of Range 1  
     

Survival Estimate of 5534 CapSure Z Atrial Placement Leads