BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1051883 · Received May 13, 2008

    Report

    Report Number
    9710014-2008-00163
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DISTURBING BACKGROUND NOISES. ALL THE EXTERNAL PARTS WERE EXCHANGED, WHICH LED TO AN IMPROVEMENT TEMPORARILY. IN 2008, THE PT WENT TO MED-EL AND REPORTED THAT HER HEARING PERCEPTION THROUGH HER SPEECH PROCESSOR IS TOO LOUD. TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR