BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3994219 · Received July 23, 2014

    Report

    Report Number
    9710014-2014-00388
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 16, 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

    THE CONCERNED DEVICES SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK IN THE AUDIO PROCESSOR BATTERY PACK WAS OBSERVED AND THAT IT WAS NOT POSSIBLE TO REMOVE THE POWER ONE ZINC AIR DISPOSABLE BATTERIES FROM THE BATTERY FRAME. ONE DAY LATER, A POPPED BATTERY WAS OBSERVED AND THE BATTERY PACK WAS FOUND BROKEN. NO INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430984 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM ZINC AIR BATTERIES MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR