BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2150461 · Received June 7, 2011

    Report

    Report Number
    9710014-2011-00179
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 ONE MONTH AGO, THE PT STARTED TO HEAR SOME NOISE OCCASIONALLY WHICH BECAME MORE AND MORE OFTEN AFTERWARDS. SINCE ONE WEEK, HE CANNOT HEAR ANYTHING WITH HIS DEVICE. REPLACING THE SPEECH PROCESSOR AS WELL AS OTHER COMPONENTS DIDN'T IMPROVE. TESTING SHOWS THAT THE DEVICE HAS MALFUNCTIONED. AN ACCIDENT OR TRAUMA IS NOT KNOWN.

    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 15 YR