BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 5

    MDR report key: 2381654 · Received December 7, 2011

    Report

    Report Number
    2381654
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 28, 2011
    Report Date
    December 7, 2011
    Manufacturer
    COCHLEAR AMERICAS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COCHLEAR AMERICAS CONFIRMED THAT THERE IS A HARD DEVICE FAILURE ON AN ALREADY IMPLANTED NUCLEUS 5 DEVICE. THIS DEVICE WAS NOT INDICATED AS A PART OF THE SEPTEMBER 2011 COCHLEAR AMERICAS RECALL. PATIENT WAS IMPLANTED 7 MONTHS AGO. THE EXTERNAL EQUIPMENT WILL NOT EVEN COMMUNICATE WITH THE INTERNAL DEVICE. THIS MEANS THERE IS NO PERCEPTION OF SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 5 IMPLANT COCHLEAR MCM COCHLEAR AMERICAS NUCLEUS 5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR