BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 3902204 · Received June 19, 2014

    Report

    Report Number
    3001587388-2014-00151
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SPV VALVE HAS BEEN ANALYZED BY OUR LABORATORY AND THE OBSTRUCTION HAS BEEN CONFIRMED. VISUAL EXAMINATION SHOWS THE PRESENCE OF MANY DRY DEPOSITS IN THE VALVE. SUCH SHUNT OBSTRUCTIONS ARE A KNOWN SHORT AND LONG TERM COMPLICATION DESCRIBED IN THE INSTRUCTIONS FOR USE AND THEY ARE NOT INDICATED OF A DEVICE MALFUNCTION, OR PROBLEMS WITH SURGICAL TECHNIQUE OR HANDLING. MOREOVER IN ORDER TO PERFORM A STRONGER ANALYSIS, SOPHYSA RECOMMENDS IN THE CHAPTER RETURN OF PRODUCTS TO RETURN AND EXPLANTED VALVE IMMERSED IN WATER (NON-SALINE), INDICATING IF NECESSARY WHETHER CLEANING HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    VALVE SPV IMPLANTED ON (B)(6) 2013 IN A PATIENT WITH REFRACTORY PARIETAL MENINGOCELE. ON (B)(6) 2014, DYSFUNCTION OF THE VALVE WITH MENINGOCELE RECURRENCE. THE SURGEON REPLACED THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360782 POLARIS ADJUSTABLE VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA POLARIS A0376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention