BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE WITH ANTECHAMBER

    MDR report key: 2220646 · Received July 15, 2011

    Report

    Report Number
    3001587388-2011-00166
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED ON (B)(6) AND THE INITIAL SETTING WAS 100. IT SEEMED TO BE FUNCTIONING PROPERLY AND THE CONDITION OF THE PT WAS IMPROVING. AFTER A WEEK, HOWEVER, THE SURGEON HAD TO CHANGE THE SETTING TO 70 BECAUSE HYDROCEPHALUS WORSENED. SINCE THEN, BOTH THE FLOW AND THE PT CONDITION SEEMED UNSTABLE, WHICH MADE HIM DECIDE TO EXPLANT THE VALVE ON (B)(6). HE WOULD LIKE TO KNOW THE ROOT CAUSE OF THIS EVENT AND IF THE VALVE IS DEFECTIVE. HE WOULD LIKE A REPLACEMENT TOO. WE NEED AN INVESTIGATION REPORT AS SOON AS POSSIBLE BECAUSE NOT ONLY THE SURGEON BUT ALSO THE PT IS WAITING FOR THE RESULT. PLEASE INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE WITH ANTECHAMBER HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE X0245

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR