BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4101735 · Received September 15, 2014

    Report

    Report Number
    9710014-2014-00460
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAGNOSTIC IMAGING HAD NOT REVEALED A COCHLEAR MALFORMATION. A 4 HOURS LONG SURGERY TOOK PLACE UNDER NAVIGATION, WHERE THE FACIAL NERVE WAS EXPOSED. DUE TO THE RISK OF FACIAL NERVE PARALYSIS THE SURGERY WAS ABORTED AND THE DEVICE REMOVED. THE DEVICE WAS REMOVED FOR ANATOMICAL REASONS. THE PATIENT WAS EXPLANTED OF THE DEVICE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570171 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT + COMPRESSED MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention