BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3823784 · Received February 20, 2014

    Report

    Report Number
    9710014-2014-00089
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 THE PT HAD SATISFYING HEARING PERFORMANCE FOR THE LAST 11 YRS. HE HIT HIS HEAD 3 WEEKS AGO, FOLLOWED BY NO LONGER HAVING ANY ACCESS TO SOUND WITH HIS COCHLEAR IMPLANT. THE EXTERNAL PARTS WERE EXCHANGED, BUT THE SITUATION REMAINED UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106704 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR