BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2090160 · Received May 16, 2011

    Report

    Report Number
    6000034-2011-00347
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED NON-AUDITORY SSENSATIONS, RESULTING IN DEVICE NON-USE. THE IMPLANTED DEVICE REMAINS

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention