BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 729483 · Received June 19, 2006

    Report

    Report Number
    3001587388-2006-00015
    Event Type
    Other
    Date Received
    June 19, 2006
    Date of Event
    February 13, 2006
    Report Date
    June 16, 2006
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE HAS NOT BEEN YET RETURNED. ANALYSIS HAS TO BE DONE.

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE WAS IMPLANTED TO A PT. IT WAS SET AT 110 MM H2O. AS THE NEUROSURGEON THOUGHT WAS EITHER SOMETHING WAS HOLDING THE VALVE WIDE OPEN OR THE PRESSURE SETTINGS WERE NOT WORKING OR WERE INACCURATE, THE VALVE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SA POLARIS (R) VALVE R0242

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other