BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1050193 · Received May 23, 2008

    Report

    Report Number
    6000034-2008-00278
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST'S REPORT, THE PATIENT SUSTAINED HEAD INJURIES IN THE AREA OF THE IMPLANT ONE MONTH TO 6 WEEKS AGO. THE PATIENT CONTRACTED MENINGITIS AFTER THE ACCIDENT. HE HAS RECOVERED FROM THE MENINGITIS AND HAS RESUMED DEVICE USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention