BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22

    MDR report key: 8963491 · Received September 5, 2019

    Report

    Report Number
    6000034-2019-01768
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED NOVEMBER 1, 2019. - ATTACHMENT: [153226 DEVICE ANALYSIS REPORT REG.PDF].

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE CI22M DEVICE WAS EXPLANTED DUE TO DEVICE EXTRUSION(DATE NOT REPORTED). REPORTEDLY, THE RECIPIENT WILL BE REIMPLANTED IN 4-6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758930 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention