BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 549505 · Received March 29, 2004

    Report

    Report Number
    3001587388-2004-00003
    Event Type
    Other
    Date Received
    March 29, 2004
    Date of Event
    February 26, 2004
    Report Date
    March 12, 2004
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER THE VALVE WAS PLACED, THE NEUROSURGEON CHANGED THE PRESSURE SETTING LOWER BUT THE PT'S VENTRICLE DID NOT BECOME SMALLER. THEREFORE, THE CUSTOMER REMOVED THE VALVE AND IMPLANTED ANOTHER 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 * M0290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other