BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3994419 · Received July 23, 2014

    Report

    Report Number
    9710014-2014-00374
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MED-EL ELEKROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FITTING SESSION, IN SITU TESTING SHOWED ALL ELECTRODE CHANNELS WITH STATUS HI, AN ACCIDENT OR TRAUMA IS NOT KNOWN. AN X-RAY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431786 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA +FLEX EAS MCM MED-EL ELEKROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1