BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 481500 · Received August 14, 2003

    Report

    Report Number
    3001587388-2003-00005
    Event Type
    Other
    Date Received
    August 14, 2003
    Date of Event
    May 26, 2003
    Report Date
    August 13, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE SOPHY ADJUSTABLE PRESSURE VALVE PATENCY WAS NOT CONFIRMED: THE ANTI-REFLUX MECHANISM WAS DEFECTIVE. AFTER CONNECTING THE SOPHY VALVE TO THE VENTRICULAR CATHETER, THE CATHETER RESERVOIR WAS PUSHED WITH THE VENTRICULAR TUBE UPSTREAM. THEN THE FILLING OF THE RESERVOIR WAS SEEN TO COME FROM THE VALVE, SIGN OF A BLOCKING AWAY FROM ITS CONE SEAT. ANOTHER SOPHY VALVE WAS IMPLANTED WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * N0104

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other