BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 620202 · Received June 6, 2005

    Report

    Report Number
    3001587388-2005-00011
    Event Type
    Other
    Date Received
    June 6, 2005
    Date of Event
    April 8, 2005
    Report Date
    May 30, 2005
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN MARCH 2005, A PT WAS OPERATED FOR A BRIAN TUMOR REMOVAL. AND A HYDROCEPHALUS APPEARED FOLLOWING THE SURGERY, TREATED BY AN EXTERNAL DRAINAGE SYSTEM. AFTER STABILIZATION OF THE PT STATUS, AN INTERNAL SHUNT WAS IMPLANTED IN 2005. IN 2005, THE IMPLANTED SM8 ADJUSTABLE PRESSURE VALVE EFFICIENCY WAS VERIFIED, USING A WATER COLUMN. VALVE DYSFUNCTION WAS CONCLUDED, BUT NO MATTER WAS NOTED ON RESERVOIR AND VENTICULAR CATHETER. AFTER REPLACING THE VALVE, THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY (R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA SOPHY(R) VALVE P0268

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR