BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS

    MDR report key: 2405219 · Received December 23, 2011

    Report

    Report Number
    2405219
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    November 16, 2011
    Report Date
    December 21, 2011
    Manufacturer
    COCHLEAR AMERICAS INC
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT COCHLEAR IMPLANT WITH A COCHLEAR CORPORATION NUCLEUS CI512 DEVICE IN SPRING OF 2011 (APPROX 7 MONTHS AGO). SHE SUBSEQUENTLY HAS DEVELOPED A FAILURE OF THE INTERNAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS INC C1512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR