BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 480570 · Received August 18, 2003

    Report

    Report Number
    3001587388-2003-00010
    Event Type
    Other
    Date Received
    August 18, 2003
    Date of Event
    October 7, 2002
    Report Date
    August 18, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EXPLANTATION FOR A FEW DYSADJUSTMENTS OBSERVED ON THE VALVE WITHOUT EXPLANTATIONS. DEVICE TESTED BEFORE VENTRICULOPERITONEAL IMPLANTATION, PLACED IN A DEPTH OF LESS 5 MM ET CONFIRMED BY AN X-RAY.

    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 * L0068

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other