BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPV ADJUSTABLE VALVE/BURR HOLE

    MDR report key: 3005852 · Received February 13, 2013

    Report

    Report Number
    3001587388-2013-00020
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 4, 2013
    Manufacturer
    SOPHYSA SA
    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)(6) 2013 RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SPVB WAS IMPLANTED ON (B)(6). A WEEK LATER, THEY CHECKED THE VENTRICLE UNDER CT SCAN BUT IT WAS NOT DIMINISHED. THEREFORE, THE SURGEON TRIED TO CHANGE THE PRESSURE SETTING FROM 110 TO 70 BUT HE WAS NOT ABLE TO. AFTER TENS OF TRIALS, HE FINALLY SUCCEEDED IN IT. HOWEVER, THE SIZE OF VENTRICLE DID NOT CHANGE FOR ANOTHER WEEK. WHEN CHECKED BY X-RAY, HE CONFIRMED THAT THE FLOW STOPPED AT THE OUTLET CONNECTOR OF THE VALVE. IT SEEMED OCCLUDED. HE REPLACED IT WITH A NEW ONE ON (B)(6). PLEASE EXAMINE THE SAMPLE TO SEE EXACTLY WHERE 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
    64212 POLARIS SPV ADJUSTABLE VALVE/BURR HOLE POLARIS SPV ADJUSTABLE VALVE/BU JXG SOPHYSA SA POLARIS Y0523

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR