BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1031937 · Received April 22, 2008

    Report

    Report Number
    9710014-2008-00129
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 16, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    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 EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF APRIL, THE CHILD BANGED HER HEAD ON THE IMPLANT SITE AGAINST ANOTHER CHILD. THE PARENTS WENT TO AN EMERGENCY HOSPITAL BUT DID NOT INFORM THE IMPLANTING CLINIC NOR MED-EL VIENNA. DURING A ROUTINE VISIT AT THE IMPLANTING CLINIC SOME TIME LATER, TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED. AT THAT TIME, THE CHILD'S MOTHER MENTIONED THE IMPACT TO HER CHILD'S HEAD. ANOTHER TESTING IS SCHEDULED FOR NEXT WEEK.

    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 7 YR