BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 485123 · Received September 17, 2003

    Report

    Report Number
    3001587388-2003-00014
    Event Type
    Other
    Date Received
    September 17, 2003
    Date of Event
    August 6, 2003
    Report Date
    September 17, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EXPLANTATION IN 2003 FOR A FEW "DYSADJUSTMENTS" (SPONTANEOUS MODIFICATIONS OF THE PRESSURE SETTINGS) OBSERVED ON THE VALVE WITHOUT EXPLANTATIONS. EXPLANTATION OF THE IMPLANT AND REPLACEMENT WITH A NEW SOPHY VALVE. NO INJURY REPORTED EXCEPT TRANSIENT NEUROLOGICAL COMPLICATIONS BEFORE REPLACEMENT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * M0270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other