BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 6970152 · Received October 23, 2017

    Report

    Report Number
    6000034-2017-01884
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 3, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON OCTOBER 24, 2017, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT REPORTEDLY DEVELOPED AN INNER EAR INFECTION AND WAS SUBSEQUENTLY TREATED WITH ANTIBIOTIC EAR DROPS. THE IMPLANTED DEVICE REMAINS AND THE PATIENT CONTINUES TO CLINICALLY MANAGED BY THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748984 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention