BEUDAMED
    FDA Adverse Event Other Summary report: N

    H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320)

    MDR report key: 1245468 · Received November 13, 2008

    Report

    Report Number
    9612007-2008-00032
    Event Type
    Other
    Date Received
    November 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION WILL BE CONDUCTED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS RECEIVED FROM THE FACILITY: THE LUMBAR PERITONEAL SHUNT WAS PLACED IN A PT FOR A CEREBRAL TUMOR. THE USER FACILITY REPORTED THAT THE PT HAD 37 MM OF PRESSURE AND SYMPTOMS OF PAPILLEDEMA. THE PT APPEARED TO BE WELL FOR FIVE DAYS POST IMPLANTATION; THEN BEGAN TO HAVE HEADACHES FOLLOWED BY CONVULSIONS. IT WAS REPORTED THAT THE SHUNT WAS OVER-DRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320) NONE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1