BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 953030 · Received November 27, 2007

    Report

    Report Number
    9710014-2007-00336
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    January 1, 2007
    Report Date
    November 27, 2007
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 AT THE THIRD FITTING IN 2007, IT WAS FOUND THAT THE GROUND PATH IMPEDANCE CHANGED ITS VALUE FROM NORMAL TO 8.89. AT THE FIRST TWO FITTINGS ESRT MEASUREMENTS WERE OBTAINED AT NORMAL LEVELS. THIS TIME ESRT WAS ONLY ABLE ON TWO ELECTRODE CHANNELS AT ABOUT 95PD. AFTER THE PT WAS GIVEN A VERY HIGH QU PROGRAMME, HE WAS ABLE TO HEAR AT AROUND 50 DB. THE PT IS TOO YOUNG TO DO SPEECH DISCRIMINATION TASKS. THERE IS NO HISTORY OF TRAUMA. TESTING WAS CARRIED OUT WHICH SHOWED HIGH IMPEDANCES ON ALL ELECTRODE CHANNELS, INDICATING 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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR