BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS KIT

    MDR report key: 1657325 · Received March 30, 2010

    Report

    Report Number
    3001587388-2010-00087
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    December 18, 2009
    Report Date
    March 29, 2010
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO MFR ON 03/01/2010. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.

    Description of Event or Problem · 1

    THEY IMPLANTED THE SPVA-2010 ON (B) (6) 2009. THEY TRIED TO CHANGE THE PRESSURE SETTINGS THE NEXT DAY BUT COULD NOT. ON (B) (6), THEY TRIED AGAIN, BUT COULD NOT. THEY SUSPECTED THAT THE PAK-2 WAS FAULTY, BUT IT WORKED ON A VALVE IMPLANTED IN ANOTHER PT. THEY LATER MANAGED TO CHANGE THE PRESSURE TO 200 MMH2O THE NEXT MONTH. HOWEVER, AS THE PT SUFFERED FROM OVERDRAINAGE, THEY REPLACED THE VALVE WITH ANOTHER COMPANY'S. THEY WANT TO KNOW WHY THEY COULD NOT CHANGE THE PRESSURE SMOOTHLY AND IF THE SELF-LOCKING SYSTEM REALLY WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS KIT HYDROCEPHALUS VALVE JXG SOPHYSA POLARIS VALVE V0368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK