BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYS

    MDR report key: 3960019 · Received May 29, 2014

    Report

    Report Number
    9710014-2014-00252
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN MONITORED BY THE CLINIC OVER THE LAST YEAR AS IMPEDANCES HAVE BEEN STEADILY RISING. THE PT'S WORD RECOGNITION HAS DECREASED ALSO. A NEW SYMPTOM HAS ARISEN OF A POP SOUND WHEN THE PT MOVES TO HEAD TO THE LEFT. A 3D CT SCAN SHOWS ONLY ONE ELECTRODE TO BE OUT OF THE COCHLEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315966 MED-EL MAESTRO COCHLEAR IMPLANT SYS SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR