BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR NUCLEUS CI512

    MDR report key: 5276664 · Received December 9, 2015

    Report

    Report Number
    5276664
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    September 8, 2014
    Report Date
    November 12, 2015
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COCHLEAR IMPLANT EXPLANT/REIMPLANT, RIGHT. RIGHT COCHLEAR IMPLANT IS A COCHLEAR CORP NUCLEUS 512 WHICH IS FAILING. NO COMPLICATIONS WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807274 COCHLEAR NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. 512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR