BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2771737 · Received October 1, 2012

    Report

    Report Number
    9710014-2012-00347
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    September 26, 2012
    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 2 1/2 WEEKS AGO THE PATIENT, IMPLANTED IN 2001, BEGAN TO HEAR THE VOICES OF PEOPLE LIKE THEY HAVE COLDS. THEN SHE HAD LOUDNESS VARIATION. SHE ONLY HEAR FOR SOME SECONDS WHEN SHE PUTS ON HER PROCESSOR. THE EXTERNAL PARTS WERE CHECKED. AN ACCIDENT OR TRAUMA IS NOT KNOWN. TELEMETRY TESTING PERFORMED IN SITU 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 C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR