BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2823436 · Received November 7, 2012

    Report

    Report Number
    6000034-2012-02155
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 OF THE IMPLANTED DEVICE. SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Required Intervention