BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 11810754 · Received May 12, 2021

    Report

    Report Number
    6000034-2021-01312
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 14, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710364 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention