BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2063368 · Received April 19, 2011

    Report

    Report Number
    6000034-2011-00272
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, SKIN FLAP REVISION SURGERY OCCURRED ON (B)(6), 2011. THIS REPORT IS FILED (B)(4), 2011. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT SKIN FLAP REVISION SURGERY ON AN UNKNOWN DATE. 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 53 YR Required Intervention