Medtronic CRM Product Performance Report

5038 CapSure VDD-2

    Product Characteristics
US Market Release Sep-98   Serial Number Prefix LEE, LEG, or LEF
Registered US Implants 8,200   Type and/or Fixation Transvenous, Atr-Vent.,Tines
Estimated Active US Implants 3,800   Polarity Quadripolar
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 6
Electrical Malfunction 5
Other 1
Number of Leads Enrolled in Study 552
Cumulative Months of Follow-Up 21,740
Number of Leads Active in Study 92
     
Qualifying Complications 5 Total  
Conductor Fracture 2  
Failure to Capture 1  
Failure to Sense 2  
     

Survival Estimate of 5038 CapSure VDD-2 Leads