BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 766047 · Received November 2, 2005

    Report

    Report Number
    3001587388-2005-00032
    Event Type
    Other
    Date Received
    November 2, 2005
    Report Date
    October 24, 2005
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO DIFFERENT TESTS, AFTER CLEANING, THE VALVE PASSED THE SETTING TEST SUCCESSFULLY AND MET THE DESIGN SPECIFICATIONS REQUIREMENTS. NO CORRECTIVE ACTION DONE: THE INSTRUCTIONS FOR USE PRECISE THAT ACCORDING TO STATISTICAL STUDIES, THE DESIRED PRESSURE SETTINGS MAY NOT BE ACHIEVED IN ONE ATTEMPT ONLY. IT MAY BE NECESSARY TO PERFORM THIS PROTOCOL TWICE OR MORE, IN ORDER TO BE CERTAIN OF THE DESIRED ADJUSTED PRESSURE. MOREOVER, THE INSTRUCTIONS FOR USE RECOMMEND TO IMPLANT THE VALVE SO THAT THE DISTANCE BETWEEN THE VALVE AND THE SKIN DOES NOT EXCEED 8 MM.

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE WAS IMPLANTED ON A PT. AS THE NEUROSURGEON DID NOT SUCCEED IN REPROGRAMMING THE VALVE, VALVE REVISION WAS OPERATED. NO PT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA POLARIS (R) VALVE P0471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other