BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 489912 · Received October 14, 2003

    Report

    Report Number
    3001587388-2003-00017
    Event Type
    Other
    Date Received
    October 14, 2003
    Date of Event
    August 11, 2003
    Report Date
    October 14, 2003
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION OF A SOPHY VALVE IN 1999 FOR HYDROCEPHALUS. EXPLANTATION IN 2003 FOR RETURN OF HYDROCEPHALOUS SYMPTOMS AND CSF PROTEIN RATE INCREASING WITHOUT EXPLANATIONS. EXPLANTATION OF THE IMPLANT. NO INJURY REPORTED.

    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 * J0308

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other