BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ADJUSTABLE VALVE/ANTECHAMBER 10-140

    MDR report key: 3963857 · Received May 20, 2014

    Report

    Report Number
    3001587388-2014-00164
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON 04/18/2014. RESULT OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    EVEN THE SPVA-140 WAS SET AT 140MMHG, THE PATIENT SUFFERED FROM SUBDURAL HEMATOMA DUE TO OVERDRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298336 POLARIS ADJUSTABLE VALVE/ANTECHAMBER 10-140 POLARIS ADJUTABLE VALVE/ANTECHAMBER JXG SOPHYSA SA POLARIS Z0367

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR