BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE 30-200

    MDR report key: 2121311 · Received May 9, 2011

    Report

    Report Number
    3001587388-2011-00116
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MFR ON (B)(4) 2011. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED AFTER (B)(6) 2009. THE PT SUFFERED FROM SUBDURAL HEMATOMA ON (B)(6), 2011 AFTER HEAD INJURY FROM A FALL. THE SURGEON FOUND THAT THE VALVE SETTING COULD NOT BE CHANGED ON (B)(6), 2011. THAT WAS IMPOSSIBLE EVEN UNDER X-RAY BY PAK2. HE WOULD LIKE TO KNOW WHY HE WOULD NOT CHANGE THE PRESSURE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE 30-200 POLARIS ADJUSTABLE VALVE JXG SOPHYSA POLARIS W0009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR