BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 20188370 · Received September 11, 2024

    Report

    Report Number
    6000034-2024-03121
    Event Type
    Injury
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED REDNESS AT THE MAGNET SITE AND THE RECEIVER/STIMULATOR WAS EXPOSED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2024, TO REPOSITION THE DEVICE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612226 NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI632 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention