BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 640495 · Received October 10, 2005

    Report

    Report Number
    3001587388-2005-00024
    Event Type
    Other
    Date Received
    October 10, 2005
    Date of Event
    July 1, 2005
    Report Date
    October 5, 2005
    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

    THIS SOPHY ADJUSTABLE PRESSURE VALVE SM8 WAS IMPLANTED IN A PATIENT WITH A PRESSURE ADJUSTED TO 120MM HG. SINCE THE PATIENT PRESENTED NEUROLOGICAL COMPLICATIONS AND URINARY INCONTINENCE, THE DOCTOR CONFIRMED BY RMI AN OVERDRAINAGE OF THE DERIVATION. VALVE REVISION WAS OPERATED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA SOPHY VALVE M0219

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other