BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE KIT

    MDR report key: 4250061 · Received August 21, 2013

    Report

    Report Number
    3001587388-2014-00259
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    January 6, 2014
    Report Date
    November 8, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE HAS BEEN ANALYSED BY OUR LABORATORY. THE MALFUNCTION HASN'T BEEN CONFIRMED. BUT GIVEN THAT THE VALVE WAS CLEANED BY THE CUSTOMER BEFORE BEING RETURNED TO THE MANUFACTURER, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    WHILE THE SPV2010 WAS FUNCTIONAL OUTSIDE THE PATIENT, ONCE CONNECTED TO THE VENTRICULAR CATHETER, IT SEEMS NOT PERMEABLE. THE SURGEON REPLACES THE VALVE WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407236 POLARIS ADJUSTABLE VALVE KIT POLARIS KIT JXG SOPHYSA SA POLARIS KIT B0001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR