BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPV ADJUSTABLE VALVE

    MDR report key: 4301328 · Received October 27, 2014

    Report

    Report Number
    3001587388-2014-00411
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WILL BE RETURNED TO SOPHYSA FOR EVAL. A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SVP SEEMS OCCLUDED IN (B)(6) 2014. THE SETTING PRESSURE OF THE VALVE IS SET TO THE HIGH PRESSURE. OCCLUSION WAS NOT IMPROVED THOUGH THE DOCTOR TRIED THE PUMPING IN THE RESERVOIR PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683543 POLARIS SPV ADJUSTABLE VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA SA POLARIS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention