BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1021897 · Received March 31, 2008

    Report

    Report Number
    9710014-2008-00100
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HAS NOT BEEN ABLE TO HEAR AS WELL AS NORMAL OVER THE PAST FEW WEEKS. THE SOUND IS INTERMITTENT AND DEPENDS ON THE PT'S HEAD MOVEMENTS. WHEN THE PT PRESSES OVER THE SITE OF THE REFERENCE ELECTRODE, THE SOUND IS CLEARER. THE IMPEDANCE VALUE OF THE REFERENCE ELECTRODE IS ABOVE 6K OHM.

    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 56 YR