BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22

    MDR report key: 15474150 · Received September 23, 2022

    Report

    Report Number
    6000034-2022-02787
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 23, 2022
    Report Date
    October 12, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON SEPTEMBER 23, 2022.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS INDICATED DEVICE FAILURE. DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON NOVEMBER 04, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON AUGUST 23, 2022 DUE TO NON-USE OF THE DEVICE. THERE ARE NO 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
    2728825 NUCLEUS 22 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention