BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 12007035 · Received June 16, 2021

    Report

    Report Number
    6000034-2021-01778
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 27, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 16, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2021 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908966 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention