BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    MDR report key: 493361 · Received October 24, 2003

    Report

    Report Number
    3001587388-2003-00018
    Event Type
    Other
    Date Received
    October 24, 2003
    Date of Event
    February 10, 2003
    Report Date
    October 23, 2003
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION IN 2003. INDICATION: HYDROCEPHALUS AFTER SUBARACHNOID HEMORRHAGE. FIRST PRESSURE SETTING AT 70 MMH2O : PT NORMAL. FROM NEAR THE END OF 2002 - BEGINNING OF 2003, SYMPTOMS OF HYDROCEPHALUS CAME BACK AGAIN. REVISION OF THE VALVE WITH A MODIFICATION OF THE PRESSURE FROM 70 TO 30 MMH2O, WITHOUT IMPROVEMENT OF THE PT HEALTH. IN 2003, EXPLANTATION DONE FOR A PARTIAL OBSTRUCTION AND REPLACEMENT WITH A NEW VALVE. NO INJURY REPORTED EXCEPT BEFORE OPERATION (TRANSIENT SYMPTOMS OF NEW HYDROCEPHALUS). THE PT PRESENTED NO MORE NEUROLOGICAL TROUBLES AFTER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHY ADJUSTABLE PRESSURE VALVE SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG SOPHYSA * M0208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other