BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FIXED PRESSURE VALVE

    MDR report key: 3093708 · Received May 1, 2013

    Report

    Report Number
    2021898-2013-00155
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED. THEREFORE, AN EVALUATION OF THEIR PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED PRELIMINARY RESULTS OF A RANDOMIZED, PARALLEL, OPEN LABEL TRIAL INVOLVING THE STUDY OF 42 PTS WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS. ACCORDING TO THE ARTICLE, 26 OF THE PTS WERE TREATED WITH A VENTRICULOPERITONEAL SHUNT, AND 5 OF THESE 26 PTS DEVELOPED A SUBDURAL HEMATOMA. THE ARTICLE STATES THAT THESE 5 PTS UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO REPLACE THEIR IMPLANTED SHUNT, AND THAT ALL 5 PTS HAD A FAVORITE 12-MONTH OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189013 UNKNOWN FIXED PRESSURE VALVE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization