BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPV ADJUSTABLE VALVE

    MDR report key: 4118065 · Received September 8, 2014

    Report

    Report Number
    3001587388-2014-00354
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SPV VALVE WAS IMPLANTED ON (B)(6) 2014. ON (B)(6), DESPITE A PRESSURE SETTING OF 200 MMH2O, AN OVERDRAINAGE IS NOTICED. THE VALVE IS EXPLANTED, REPLACED BY ANOTHER SPV AND SENT TO SOPHYSA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550957 POLARIS SPV ADJUSTABLE VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA POLARIS A0463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention