BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 511122 · Received February 2, 2004

    Report

    Report Number
    3001587388-2004-00002
    Event Type
    Other
    Date Received
    February 2, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 30, 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 (ROTOR BLOCKING).

    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 * M0143

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other