BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 501622 · Received December 4, 2003

    Report

    Report Number
    3001587388-2003-00024
    Event Type
    Other
    Date Received
    December 4, 2003
    Date of Event
    August 19, 2003
    Report Date
    December 4, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, A SOPHYSA SHUNT WAS IMPLANTED IN A PT. THE SOHY ADJUSTABLE PRESSURE VALVE WAS SET TO MEDIUM PRESSURE. IN MAY 2003, SOME TROUBLES APPEAR FOR THE PT. THE VALVE WAS SET FROM MEDIUM PRESSURE TO HIGH PRESSURE, BUT WITH A NOTED PERSISENT OVERDRAINAGE. THE ICP IS UNK AND NO 'OVERPROTEINORACHIE' IS NOTED. THREE MONTHS LATER, THE NEUROSURGEON SUCCESSFULLY OPERATED THE PT FOR REVISION. A NEW VALVE WAS USED 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 * M0174

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R