BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE 30-200

    MDR report key: 2941615 · Received December 20, 2012

    Report

    Report Number
    3001587388-2012-00474
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WILL BE ANALYZED BY SOPHYSA AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SPV WAS IMPLANTED AS VP-SHUNT IN (B)(6) 2012. THE INITIAL SETTING WAS 70. IT WAS THEN CHANGED TO 30 AFTER ONE MONTH, THEN (B)(6). SINCE THEN, IT WAS CHANGED OT 30, 40, 50, 60, 70, ONE POSITION A MONTH, AND FINALLY 110 IN (B)(6). HOWEVER, THEN HE TRIED TO CHANGE THE PRESSURE SETTING AGAIN ON (B)(6) UNDER X-RAY, HE WAS NOT ABLE TO. THE FLOW ALSO SEEMED NEARLY BLOCKED. THEREFORE, HE REPLACED THE VALVE ON (B)(6). PLEASE EXAMINE THE SAMPLE TO SEE IF IT IS OCCLUDED AND IF THE PRESSURE SETTING CAN BE CHANGED AT YOUR SITE. THE CUSTOMER ALSO WOULD LIKE TO KNOW THE MEASURED VALUES OF EACH PRESSURE POSITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR