BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 19926008 · Received August 7, 2024

    Report

    Report Number
    6000034-2024-02724
    Event Type
    Injury
    Date Received
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036580
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579704 NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI632 NA 09321502036580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention