BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3131185 · Received May 22, 2013

    Report

    Report Number
    9710014-2013-00200
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    November 1, 2012
    Report Date
    May 17, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX MONTHS AGO THE PT FELL OUT OF HER BABY CRADLE. BEFORE THE ACCIDENT, THE PT RESPONDED TO SOUND, BUT NOW SHE NO LONGER ANSWERS TO HER NAME. THE PT COMPLAINS OF HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226639 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR