BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2883988 · Received December 21, 2012

    Report

    Report Number
    6000034-2012-02379
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE PATIENT'S MOTHER, THE PATIENT DEVELOPED SWELLING AND INFECTION AROUND THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN) ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED AS OF THE DATE OF THIS REPORT, (B)(6) 2012. IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE, AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention