BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2844616 · Received November 12, 2012

    Report

    Report Number
    9710014-2012-00391
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 CHECK AS PART OF A F/U VISIT, HER 4 YEAR CONTROL, IT WAS SEEN THAT THERE ARE NOW 4 SHORT CIRCUITS AND ONE EXTRA COCHLEAR ELECTRODE CHANNEL. HER WORD SCORES HAVE DETERIORATED IN COMPARISON TO HER ONE YEAR SCORES. THERE IS NO REPORT OF ANY TRAUMA OR HEAD INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR