BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 14881880 · Received June 30, 2022

    Report

    Report Number
    6000034-2022-01894
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 7, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JULY 1, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609895 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention