BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE

    MDR report key: 2220630 · Received July 15, 2011

    Report

    Report Number
    3001587388-2011-00165
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 9, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED ON MAY 26TH BUT THE CONDITION OF THE PT DID NOT IMPROVE. THE SURGEON FOUND THE DISTAL CATHETER OCCLUDED UNDER X-RAY ON MAY 30TH AND THEN EXPLANTED THE SHUNT SYS. THE CATHETER WAS OCCLUDED BY BLOOD CLOT. THIS OCCLUDED SPOT WAS DISCARDED BY THE DR AT THE HOSP. HE WOULD LIKE TO KNOW WHY ONLY THE CATHETER WAS OCCLUDED BECAUSE THE RUBY BALL AREA, THE NARROWEST SPOT, DID NOT SEEM OCCLUDED. ALSO, THE PRESSURE SETTING WAS INITIALLY 70 BUT HE SAW UNDER X-RAY THAT IS HAD BEEN CHANGED TO 200 AUTOMATICALLY. HE IS WONDERING IF THE SELF LOCKING MECHANISM IS NOT FUNCTIONING. PLEASE INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE X0508

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR