BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HV LIMBAR VALVE SYS WHITE, TALL CHILD/ADULTS

    MDR report key: 2465180 · Received February 21, 2012

    Report

    Report Number
    9612007-2012-00004
    Event Type
    Injury
    Date Received
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A HV LUMBAR VALVE WAS IMPLANTED ON (B)(6) 2011. THE PT REPORTEDLY DEVELOPED A PSEUDOMENINGOCELES TO HIS LUMBAR AND FLANK INCISIONS POST OPERATIVELY. ON (B)(6) 2012, AN EXPLORATION WAS DONE BY HIS SURGEON, BUT THE SURGEON WAS UNABLE TO IDENTIFY THE LEAK SITE ALONG THE SYSTEM. THE PT REDEVELOPED PSEUDOMENINGOCELES AND THE SHUNT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HV LIMBAR VALVE SYS WHITE, TALL CHILD/ADULTS DP VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR