BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2792434 · Received October 9, 2012

    Report

    Report Number
    9710014-2012-00355
    Event Type
    Other
    Date Received
    October 9, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 4, 2012
    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 THAT THE PATIENT FELL FROM THE 4TH FLOOR A WHILE AGO. HE SUFFERED FROM SEVERAL SKULL FRACTURES AND WENT INTO A COMA FOR 6 MONTHS. HIS BROTHER REPORTED THAT HIS HEARING WAS NORMAL PRIOR TO THE ACCIDENT. THE PATIENT LOST HIS HEARING AFTER THE ACCIDENT. CI SURGERY WAS CARRIED OUT ON (B)(6) 2012. THE PATIENT HAS NOT SHOWN ANY RESPONSE SINCE THE INITIAL FITTING. ACCORDING TO THE LOCAL SURGEONS, THE POST-OP X-RAY CONFIRMS THE CORRECT POSITION OF THE IMPLANT AND THE ELECTRODE. TESTING SHOWS THAT THE DEVICE IS WORKING WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR