BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8963428 · Received September 5, 2019

    Report

    Report Number
    6000034-2019-01686
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 19, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502007320
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 05, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED OCCASIONAL PAIN AND ITCHING IN THE IMPLANTED EAR, A REDDISH AND WET SPOT WERE OBSERVED UNDER THE DEVICE COIL MAGNET. THE INFORMATION RECEIVED IS REPORTABLE TO FDA DUE TO POSSIBLE ADMINISTRATION OF AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761216 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (CA) NI 09321502007320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention