BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3940958 · Received June 24, 2014

    Report

    Report Number
    9710014-2014-00310
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367575 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +FLEX EAS MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention