BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 821452 · Received October 29, 2004

    Report

    Report Number
    3001587388-2004-00018
    Event Type
    Other
    Date Received
    October 29, 2004
    Date of Event
    September 13, 2004
    Report Date
    October 29, 2004
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE RETURNED DRY WITH NO DIFFICULTY TO FLUSH AIR OR WATER. THE ALLEGED FAILURE COULDN'T BE DUPLICATED. THE VALVE BEHAVIOR IS NORMAL. THE DHR INDICATES THE CONFORMITY OF THE VALVE DURING THE FINAL ACCEPTANCE CHECKINGS. THE INSTRUCTION FOR USE JOINT WITH EACH SOPHYSA MEDICAL DEVICE SET OUT SPECIFIC PRECAUTION NOTING TO AVOID TESTING DEVICE BEFORE IMPLANTATION. SO NO CORRECTIVE ACTION WILL BE DONE.

    Description of Event or Problem · 1

    ON SEPTEMBER 2004, THIS SM8 SOPHY ADJUSTABLE PRESSURE VALVE WAS TESTED BEFORE IMPLANTATION. IN ORDER TO CONFIRM THE SHUNT PATENCY, THE NEUROSURGEON TRIED TO INJECT WATER WITHOUT RESULT. HE THOUGHT THE VALVE OCCLUDED DURING THAT PROCEDURE. THEREFORE, THE NEUROSURGEON DIDN'T IMPLANT THE DEVICE. TROUBLE WAS SOLVED BY USING ANOTHER VALVE. NO INJURY WAS FOUND TO THE PT DUE TO THE VALVE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SOPHY(R) VALVE P0159

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR