Medtronic CRM Product Performance Report

4533 CapSure Z

    Product Characteristics
US Market Release Not US released   Serial Number Prefix LCB
Registered US Implants NA   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants NA   Polarity Unipolar
Advisories None   Steroid Yes

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 0
Electrical Malfunction 0
Other 0
Number of Leads Enrolled in Study 206
Cumulative Months of Follow-Up 11,286
Number of Leads Active in Study 16
     
Qualifying Complications 4 Total  
Failure to Capture 1  
Failure to Sense 1  
Lead Dislodgement 1  
Oversensing 1  
     

Survival Estimate of 4533 CapSure Z Atrial Placement Leads