BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE WITH ANTECHAMBER

    MDR report key: 2220650 · Received June 30, 2011

    Report

    Report Number
    3001587388-2011-00169
    Event Type
    Malfunction
    Date Received
    June 30, 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 DR TRIED TO CHANGE THE VALVE SETTING BUT COULD NOT CHANGE EVEN WITH PAK2. HE REPLACED THE VALVE ON (B)(6) 2011. HE WOULD LIKE TO KNOW THE ROOT CAUSE OF THIS EVENT. AFTER EXTRACTING THE VALVE, THE DR TRIED TO CHANGE THE PRESSURE SEVERAL TIMES AND FINALLY SUCCEEDED IN DOING IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR