BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3122627 · Received May 16, 2013

    Report

    Report Number
    9710014-2013-00160
    Event Type
    Other
    Date Received
    May 16, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 8, 2013
    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 COULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BILATERAL IMPLANTATION SURGERY ON (B)(6) 2013, WAS UNEVENTFUL. POST OP X-RAY INDICATED THAT ELECTRODE ARRAY HAD EXTRUDED FROM COCHLEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216601 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO