BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 549826 · Received July 29, 2004

    Report

    Report Number
    MW1032838
    Event Type
    Death
    Date Received
    July 29, 2004
    Date of Event
    July 28, 2003
    Report Date
    July 28, 2004
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR MADE BY MEDTRONIC, INC. AND SPINALPAK MADE BY BIOLECTRON, INC. IN 2003 - DEFIBRILLATOR INSERTED. A FEW WEEKS LATER, DEFIBRILLATOR WENT OFF SO HARD PT FELL FACE DOWN AND CRACKED A VERTEBRAE IN NECK. THIS REQUIRED NEURO SURGERY IN WHICH A REP REPRESENTING BIOLECTRON, INC. PUSHED A DEVICE THAT REP INSISTED WOULD SPEED/AIDE PT'S HEALING. FAMILY MEMBERS INQUIRED IF IT WOULD COUNTERACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEFIBRILLATOR LWS MEDTRONIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death