BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082410 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00236
    Event Type
    Other
    Date Received
    July 29, 2008
    Date of Event
    January 1, 2007
    Report Date
    July 15, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE 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 MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN HEARING BELL-LIKE SOUNDS SINCE HER FIRST FITTING. THE SURGEON CONFIRMED THAT THERE ARE 5 ELECTRODE CHANNELS OUTSIDE THE COCHLEAR, WHICH HE INTENDS TO RE-POSITION DURING A REVISION SURGERY.

    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 63 YR