BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 713079 · Received April 27, 2006

    Report

    Report Number
    3001587388-2006-00006
    Event Type
    Other
    Date Received
    April 27, 2006
    Date of Event
    March 2, 2006
    Report Date
    April 24, 2006
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS POLARIS ADJUSTABLE PRESSURE VALVE WAS IMPLANTED TO A PT (IMPLANTATION DATE IS UNK). AS IT WAS IMPOSSIBLE TO ADJUST THE PRESSURE OF THE VALVE, THE VALVE WAS EXPLANTED. MOREOVER, THE NEUROSURGEON REMARKED THAT THE RUBY BALL INSIDE THE VALVE CAME OUT OF ITS SEAT.

    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 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other