BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 19718082 · Received July 11, 2024

    Report

    Report Number
    6000034-2024-02395
    Event Type
    Injury
    Date Received
    July 11, 2024
    Report Date
    June 14, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036573
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY TO EXCISE THE SKIN AROUND THE EXPOSURE AND CLOSE THE WOUND UNDER GENERAL ANESTHESIA ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346321 NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI622 NA 09321502036573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention