BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 11869030 · Received May 24, 2021

    Report

    Report Number
    6000034-2021-01425
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 27, 2021
    Report Date
    April 27, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021, DUE TO THE PATIENT EXPERIENCING POOR PERFORMANCE WITH DEVICE USE. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765956 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention