BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2241063 · Received August 16, 2011

    Report

    Report Number
    9710014-2011-00240
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    August 4, 2011
    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 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 HAS DEVELOPMENTAL DIFFICULTIES. HE WAS BILATERALLY IMPLANTED ON (B)(6), 2007. FROM THE BEGINNING THE RIGHT EAR WAS THE DOMINANT EAR, AND HEARING, LISTENING AND LANGUAGE DEVELOPMENT WAS RELATED TO THE RIGHT EAR. A YEAR AGO, IT WAS OBSERVED THAT THE PT WAS NOT RESPONDING THE WAY HE USED. HIS SPEECH DEVELOPMENT WAS SLOW AND ALMOST STOPPED. HE WAS NOT AWARE OF SOUND. THE EXTERNAL PARTS WERE REPLACED SEVERAL TIMES, BUT THE SITUATION REMAINED. TESTING SHOWS THAT THE DEVICE IS FUNCTIONAL.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR