BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 1760331 · Received July 16, 2010

    Report

    Report Number
    6000034-2010-00462
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    May 15, 2010
    Report Date
    July 2, 2010
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 PAIN WHEN USING THE IMPLANT RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention