BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 509045 · Received January 22, 2004

    Report

    Report Number
    3001587388-2004-00001
    Event Type
    Other
    Date Received
    January 22, 2004
    Date of Event
    October 7, 2003
    Report Date
    January 20, 2004
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VP SHUNT REPLACEMENT BECAUSE OF DYSFUNCTION OF THE VALVE. AFTER REMOVING THE VALVE, IT WAS NOTED A DISCONNECTION OF THE INLET CONNECTOR FROM THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * M0299

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other