BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093370 · Received April 19, 2011

    Report

    Report Number
    9710014-2011-00124
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 COMPLAINED THAT THE HEARING IMPRESSION BECOMES WEAK AFTER A CERTAIN TIME WHEN WEARING THE PROCESSOR. SINCE A FEW DAYS, SHE CANNOT HEAR ANYTHING WITH HER CI, ALTHOUGH ALL EXTERNAL PARTS WERE EXCHANGED. TESTING SHOWS THAT THE DEVICE HAS MALFUNCTIONED. AN ACCIDENT IS NOT KNOWN.

    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 16 YR