Medtronic CRM Product Performance Report

5033 CapSure Z

    Product Characteristics
US Market Release Feb-96   Serial Number Prefix LDK
Registered US Implants 2,400   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 700   Polarity Unipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 6
Electrical Malfunction 1
Other 3
Number of Leads Enrolled in Study 1,899
Cumulative Months of Follow-Up 96,195
Number of Leads Active in Study 263
     
Qualifying Complications 26 Total  
Cardiac Perforation 1  
Conductor Fracture 7  
Failure to Capture 11  
Impedance Out of Range 4  
Insulation (not further defined) 1  
Lead Dislodgement 2  
     

Survival Estimate of 5033 CapSure Z Ventricular Placement Leads