Medtronic CRM Product Performance Report

5023, 5023M CapSure SP

    Product Characteristics
US Market Release Nov-88   Serial Number Prefix SX or LAS
Registered US Implants 9,900   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 2,300   Polarity Unipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 15
Electrical Malfunction 7
Other 0
Number of Leads Enrolled in Study 1,353
Cumulative Months of Follow-Up 70,587
Number of Leads Active in Study 470
     
Qualifying Complications 15 Total  
Conductor Fracture 2  
Extra Cardiac Stimulation 4  
Failure to Capture 8  
Impedance Out of Range 1  
     

Survival Estimate of 5023,5023M CapSure SP Ventricular Placement Leads