Medtronic CRM Product Performance Report

4033 CapSure Z

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

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 2
Electrical Malfunction 0
Other 0
Number of Leads Enrolled in Study 539
Cumulative Months of Follow-Up 28,545
Number of Leads Active in Study 39
     
Qualifying Complications 10 Total  
Conductor Fracture 1  
Failure to Capture 8  
Impedance Out of Range 1  
     

Survival Estimate of 4033 CapSure Z Ventricular Placement Leads