BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2900625 · Received January 7, 2013

    Report

    Report Number
    6000034-2013-00038
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT DURING MRI (1.5 TESLA). THE PATIENT'S HEAD WAS WRAPPED AS AN APPROVED INDICATION IN (B)(4).IT IS UNKNOWN IF THERE ARE PLANS REPLACE THE MAGNET AS OF THE DATE OF THIS REPORT, (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7888 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention