BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 740775 · Received July 14, 2006

    Report

    Report Number
    2938836-2006-00537
    Event Type
    Malfunction
    Date Received
    July 14, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 14, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CMRD
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD.

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REP REPORTED THAT THE DEVICE ENTERED HARDWARE VVI. THE PT WILL BE PLACED ON EXTERNAL MONITORING AND A REPLACEMENT WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM LWS ST. JUDE MEDICAL, INC., CMRD V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR THERAPY DATES: