BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT SYSTEM SOUNDTEC DEVICE

    MDR report key: 493964 · Received October 27, 2003

    Report

    Report Number
    MW1029969
    Event Type
    Injury
    Date Received
    October 27, 2003
    Date of Event
    April 18, 2002
    Report Date
    October 9, 2003
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    MPV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SOUNDTEC DEVICE IMPLANTED WITHOUT WARNINGS FROM DR OR MAKER TO HAZARD OF PT WORK AREA. UPON RETURNING TO WORK PT FELT BLOW TO RIGHT SIDE OF HEAD DESCRIBED AS BASEBALL BAT BLOW. DR. STUMPED - AFTER WEEKS OF VARIOUS MEDICATION - SUDDENLY REALIZED PT WORKED AROUND HIGH MAGNETIC MACHINERY. CONTACT CREATED A TORQUE, CAUSED RATTLING IN EAR. DEVICE REMOVED WITHOUT WARNINGS FROM DR OR SOUNDTEC AS TO POSSIBLE HAZARDS, NOW PT HAS CONTINOUS RINGING, VERITGO, NAUSEA, NO TASTE ON RIGHT SIDE OF TONGUE. ALSO BEFORE IMPLANT PT HAD 84% SPEECH DISCRIMINATION NOW HAS 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT SYSTEM SOUNDTEC DEVICE IN THE EAR IMPLANT MPV SOUNDTEC, INC. NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R