BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS

    MDR report key: 1962555 · Received March 15, 2010

    Report

    Report Number
    1962555
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 10, 2010
    Manufacturer
    COCHLEAR AMERICAS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS DEVELOPED A PARTIAL DEVICE FAILURE, AND THE DEVICE HAS FUNCTIONED SO POORLY IN RECENT WEEKS THAT SHE DISCONTINUED ALL USE OF THE RIGHT COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS COCHLEAR IMPLANT MCM COCHLEAR AMERICAS C122M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR