BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 722718 · Received June 6, 2006

    Report

    Report Number
    3001587388-2006-00010
    Event Type
    Other
    Date Received
    June 6, 2006
    Date of Event
    April 4, 2006
    Report Date
    May 24, 2006
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS SOPHY ADJUSTABLE PRESSURE VALVE WAS IMPLANTED TO A PT FOR VP SHUNTING IN 2001. AS OVERDRAINAGE WAS OBSERVED, HE NEUROSURGEON REPLACED THE VALVE BY ANOTHER VALVE IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA SOPHY (R) VALVE K0240

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other