BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082332 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00227
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    November 1, 2007
    Report Date
    July 7, 2008
    Manufacturer
    MED-EL ELECKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    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 SINCE 2007, THE PATIENT HAS HAD VARIATIONS IN THE VOLUME OF SOUND. IT WAS BELIEVED THAT THESE DIFFICULTIES HAD BEEN RESOLVED, HOWEVER, THE PATIENT HAS ONCE AGAIN ISSUES WITH SOUND FLUCTUATIONS. VOICES CAN BE VERY SOFT, BUT THE TELEVISION IS VERY LOUD. THE PATIENT IS HAVING DIFFICULTIES IN UNDERSTANDING ORAL SPEECH. 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 ELECKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR