BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2833520 · Received October 30, 2012

    Report

    Report Number
    9710014-2012-00390
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ROUTINE 4 MONTHS AFTER IMPLANTATION REVIEW, THE TESTING CARRIED OUT SHOWED 8 ELECTRODE CHANNELS HAD HI IMPEDANCES AND 2 ELECTRODE CHANNELS HAD SHORT CIRCUITS. TESTING WAS REPEATED BUT THE SAME RESULT WAS OBTAINED. THERE HAS BEEN NO REPORTED FALL OR HEAD TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR