BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS

    MDR report key: 7070133 · Received November 30, 2017

    Report

    Report Number
    3001587388-2017-17529
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    September 19, 2017
    Report Date
    January 24, 2018
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    PMA / PMN Number
    K042481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED VALVE WAS RETURNED TO OUR FACILITY AND ANALYZED FOLLOWING OUR QUALITY CONTROL PROCEDURE. THE VALVE AND THE RESERVOIR ARE CLEAN WITH COLORLESS LIQUID INSIDE: HOWEVER THE VALVE WAS NOT RETURNED IN STERILE WATER AS RECOMMENDED IN IFU, THE ANALYSIS CAN BE MORE COMPLICATED TO PERFORM. THE ROTOR IS SET ON ITS FIFTH POSITION : HIGHT PRESSURE. VISUAL EXAMINATION: SEVERAL MARKS ARE PRESENTS ON THE BODY ON THE VALVE. PRESENCE OF ORANGE/PINK COLORATION ARE VISIBLE ON THE MAGNETS. FUNCTIONAL EXAMINATION: THE ABILITY OF THE VALVE TO PERFORM AS INTENDED WAS TESTED. CIRCULATION OF AIR AND ALCOHOL REMAINS POSSIBLE. PROGRAMMING AND LOCKING OF THE VALVE ARE NOT CONFORMING TO THE SPECIFICATIONS: VALVE TENDS TO REMAIN OPEN EVEN WHEN THE PROGRAMMING MAGNET IS TAKEN AWAY FROM THE VALVE. BOTH MICRO-MAGNETS OF THE VALVE SEEM POSSIBLE TO MOVE WITH AN EXTERNAL MAGNETIC FIELD. IN CONCLUSION, ACCORDING TO OUR FUNCTIONAL TESTS, THE VALVE RETURNED DOES NOT MEET ITS SPECIFICATIONS CONCERNING ROTATION TESTS. ADDITIONAL TESTS ARE ON-GOING TO DETERMINE THE ROOT CAUSES.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A VENTRICULO PERITONEAL DERIVATION. ON (B)(6) 2017, DUE TO FEELING SICK AND POOR APPETITE, THE PATIENT CAME TO THE HOSPITAL. THE VALVE WAS ADJUSTED TO ITS LOWEST PRESSURE AND WAS CHANGED TO THE MIDDLE PRESSURE, REDUCING THE SYMPTOMS. SEVERAL DAYS AFTER, THE SURGEON OBSERVED SHRINKING CEREBRAL VENTRICLES AND DECIDED TO INCREASE THE VALVE PRESSURE. AFTER SEVERAL DAYS, OF CHECKING OF PRESSURE BY X-RAY, THE USERS OBSERVED THE CHANGE IN PRESSURE OF THE VALVE. IN ADDITION, THEY OBSERVED THAT THE SHUTTLES CONTAINING THE MICRO MAGNETS WERE NOT LOCKED AND THE PRESSURES COULD BE CHANGED EASILY BY BRINGING A MAGNET CLOSE TO THE VALVE.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A VENTRICULO PERITONEAL DERIVATION. ON (B)(6) 2017, DUE TO FEELING SICK AND POOR APPETITE, THE PATIENT CAME TO THE HOSPITAL. THE VALVE WAS ADJUSTED TO ITS LOWEST PRESSURE AND WAS CHANGED TO THE MIDDLE PRESSURE, REDUCING THE SYMPTOMS. SEVERAL DAYS AFTER, THE SURGEON OBSERVED SHRINKING CEREBRAL VENTRICLES AND DECIDED TO INCREASE THE VALVE PRESSURE. AFTER SEVERAL DAYS, OF CHECKING OF PRESSURE BY X-RAY, THE USERS OBSERVED THE CHANGE IN PRESSURE OF THE VALVE. IN ADDITION, THEY OBSERVED THAT THE SHUTTLES CONTAINING THE MICRO MAGNETS WERE NOT LOCKED AND THE PRESSURES COULD BE CHANGED EASILY BY BRINGING A MAGNET CLOSE TO THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850986 POLARIS POLARIS ADJUSTABLE VALVE JXG SOPHYSA SA SPVA-140 B0513

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention