Medtronic CRM Product Performance Report

5034 CapSure Z

    Product Characteristics
US Market Release Feb-96   Serial Number Prefix LDF
Registered US Implants 56,300   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 17,000   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 85
Electrical Malfunction 31
Other 11
Number of Leads Enrolled in Study 1,594
Cumulative Months of Follow-Up 82,761
Number of Leads Active in Study 228
     
Qualifying Complications 13 Total  
Conductor Fracture 1  
Failure to Capture 9  
Failure to Sense 1  
Impedance Out of Range 1  
Lead Dislodgement 1  
     

Survival Estimate of 5034 CapSure Z Ventricular Placement Leads