BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2111960 · Received June 2, 2011

    Report

    Report Number
    6000034-2011-00388
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 25, 2011
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    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 RECEIVED A STEROID INJECTION OF THE SKIN FLAP AROUND THE IMPLANT SITE. 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 CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention