BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE 30-200

    MDR report key: 2219042 · Received August 4, 2011

    Report

    Report Number
    3001587388-2011-00247
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED ON (B)(6), AFTER THE PT SUFFERED FROM SAH ON (B)(6). ON (B)(6), OCCLUSION WAS CONFIRMED. THEREFORE, ONLY THE VALVE WAS REPLACED WITH A NEW SPV ON (B)(6). THIS PT SHOWS HIGH CSF PROTEIN. THE DR WOULD LIKE TO KNOW EXACTLY WHERE THE VALVE IS OCCLUDED. PLEASE INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS ADJUSTABLE VALVE 30-200 HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE X0220

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR