BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1812515 · Received August 16, 2010

    Report

    Report Number
    9710014-2010-00258
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 EVALUATION. 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 CHILD HAS A SUDDEN LOUD UNPLEASANT SOUND SENSATION AND TAKES OFF THE DEVICE. IT HAPPENS ANY TIME AFTER THE CHILD PUTS ON THE DEVICE. TESTINGS CARRIED OUT WERE ALL WITHIN NORMAL LIMITS. THE EXTERNAL PARTS HAVE BEEN EXCHANGED BUT WITHOUT IMPROVEMENT. NO PHYSICAL INJURY INCLUDING HEAD TRAUMA HAS BEEN REPORTED. X-RAY SHOWS THE IMPLANT AT ITS PROPER PLACE WITHOUT ANY MIGRATION OF THE ELECTRODE ARRAY. PERFORMANCE WAS ABSOLUTELY OK BEFORE THIS PROBLEM STARTED.

    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 6 YR