BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3111809 · Received May 7, 2013

    Report

    Report Number
    9710014-2013-00173
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 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 THE PT ATTENDED THE SPANISH MED-EL OFFICE TO CHECK TO CHECK THE STATUS OF HIS AUDIO PROCESSOR AS HE WAS NO LONGER ABLE TO HEAR ANYTHING SINCE THE DAY BEFORE. AFTER SEVERAL TESTS IT WAS ASCERTAINED THAT THE EXTERNAL COMPONENTS WERE FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197785 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR