BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8958872 · Received September 4, 2019

    Report

    Report Number
    6000034-2019-01674
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    August 14, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, AN REVISION SURGERY WAS PERFORMED (DATE NOT REPORTED) FOR THE RECIPIENT DUE TO NO AUDITORY RESPONSE WITH ELECTRODES 1 TO 12. THE DETAILS OF THE DEVICE HAS NOT BEEN REPORTED AS THE DATE OF THIS REPORT ON SEPTEMBER 04, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752952 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention