BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 20298973 · Received September 25, 2024

    Report

    Report Number
    6000034-2024-03247
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    October 28, 2024
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. HARDWARE EXCHANGE / TROUBLESHOOTING / REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240255 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention| O