Medtronic CRM Product Performance Report

4003, 4003M CapSure

    Product Characteristics
US Market Release Jul-86   Serial Number Prefix IH or LAX
Registered US Implants 38,000   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 5,300   Polarity Unipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 24
Electrical Malfunction 60
Other 2
Number of Leads Enrolled in Study 711
Cumulative Months of Follow-Up 47,264
Number of Leads Active in Study 146
     
Qualifying Complications 12 Total  
Conductor Fracture 1  
Extra Cardiac Stimulation 2  
Failure to Capture 6  
Failure to Sense 1  
Oversensing 2  
     

Survival Estimate of 4003, 4003M CapSure Ventricular Placement Leads