BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYS

    MDR report key: 4180405 · Received October 15, 2014

    Report

    Report Number
    9710014-2014-00527
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 17, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI CODE NOT AVAILABLE FOR THIS DEVICE. THE DEVICE WAS RETURNED TO THE MFR WHERE IT WILL BE INVESTIGATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE ISSUED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUDIO PROCESSOR WAS HEATING UP WITHIN 30 SECONDS AFTER BEING TURNED ON. THE DEVICE WAS NOT IN CONTACT WITH THE PT'S HEAD. NO INJURY WAS OBSERVED. THE EXTERNAL DEVICE HAS NOW BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654136 MED-EL MAESTRO COCHLEAR IMPLANT SYS NONE MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO