BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE 30-200

    MDR report key: 3171863 · Received May 23, 2013

    Report

    Report Number
    3001587388-2012-00328
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    August 23, 2012
    Report Date
    May 23, 2013
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE HAS BEEN ANALYZED. ACCORDING TO OUR LABORATORY RESULTS, THE ALLEGED FAILURE COULD NOT BE DUPLICATED AND THE VALVE WAS FREE FROM ANY OCCLUSION. OTHERWISE, THE SETTING MECHANISM MEETS THE REQUIREMENTS AND ALL THE PRESSURE MEASUREMENTS ARE WITHIN THE PRODUCTION SPECIFICATIONS. THE LACK OF IMPROVEMENT OF THE PT CONDITION MET BY THE NEUROSURGEON SEEMS NOT BE DUE TO THE VALVE. IT COULD BE DUE TO AN OBSTRUCTION OF THE SHUNT CATHETERS OR TO A LACK OF SUITABILITY OF THE VALVE MODEL WITH REGARDS TO THE PT'S CONDITION. THE SHUNT CATHETERS WERE NOT RETURNED, THUS NOT ANALYZED. SHUNT OBSTRUCTION IS A KNOWN SHORT AND LONG TERM COMPLICATION DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    SYMPTOMS OF HYDROCEPHALUS DID NOT IMPROVE FOR ONE WEEK AFTER IMPLANTATION. DURING THAT TIME, THE DOCTOR CHANGED THE PRESSURE SETTING FROM 110 TO 70 BUT HE SAW NO CHANGE IN THE PT CONDITION. SINCE HE HAD NEVER SET THE PRESSURE UNDER 70, HE DECIDED TO EXCHANGE THE VALVE WITH A NEW ONE, THINKING THE VALVE WAS NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228954 POLARIS ADJUSTABLE VALVE 30-200 POLARIS ADJUSTABLE VALVE JXG SOPHYSA POLARIS Y0636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK