BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3882559 · Received June 19, 2014

    Report

    Report Number
    6000034-2014-00845
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    August 11, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED AUGUST 14, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND SWELLING AROUND THE IMPLANT SIDE WITH DIZZINESS AND NAUSEA. THE DEVICE WAS EXPLANTED ON (B)(6) 2014. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361722 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention