BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1060688 · Received June 13, 2008

    Report

    Report Number
    MW5007296
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    March 11, 2008
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT CAME IN FOR A ROUTINE CHECK AT THE DEVICE CLINIC AND FOUND TO HAVE A LEAD MALFUNCTION. IN '08, PATIENT UNDERWENT REMOVAL OF THE OLD CARDIAC DEFIBRILLATOR AND IMPLANTATION OF NEW CARDIAC DEFIBRILLATOR IN OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL VENTRICULAR LEAD (IMPLANTED) LWS 1580

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention