BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22

    MDR report key: 11052405 · Received December 21, 2020

    Report

    Report Number
    6000034-2020-03561
    Event Type
    Injury
    Date Received
    December 21, 2020
    Report Date
    December 4, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON DECEMBER 22, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED IN READINESS FOR AN MRI. THE PATIENT WAS CURRENTLY NOT USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514029 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention