BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1881174 · Received October 5, 2010

    Report

    Report Number
    9710014-2010-00316
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    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 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 THE PT IS NO LONGER ABLE TO HEAR WITH HIS DEVICE. HE VISITED HIS DISTRIBUTOR AS HE THOUGHT THE PROBLEM WAS CAUSED BY THE EXTERNAL SPEECH PROCESSOR. AFTER UPGRADING THE SPEECH PROCESSOR TO A NEWER MODEL, THE SITUATION REMAINED. NO HEAD TRAUMA WAS REPORTED. TESTING SHOWS 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 61 YR