BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS ADJUSTABLE VALVE / 5 PRESS.

    MDR report key: 9538599 · Received January 2, 2020

    Report

    Report Number
    3001587388-2019-19620
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    December 14, 2019
    Report Date
    February 12, 2020
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH DEVICE EVALUATION CARRIED OUT BY OUR QUALITY CONTROL DEPARTMENT, ALL THE FUNCTIONAL TESTS WERE SUCCESSFUL AND THE VALVE WAS FOUND TO BE COMPLIANT. THE SUBJECT DEVICE WAS NOT DEFECTUOUS, THE USER MAY HAVE SELECTED AN INADAPTATED VALVE FOR THE PATIENT'S NEEDS (INADAPTED PRESSURE).

    Description of Event or Problem · 0

    THE SURGEON SELECTED AND IMPLANTED A POLARIS VALVE (SPV) BUT THE PRESSURE RANGE WAS NOT ADAPTED TO THE PATIENT (TOO HIGH). THE VALVE WAS THEREFORE EXPLANTED AND ANOTHER VALVE WITH VERY LOW PRESSURE WAS IMPLANTED INSTEAD.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED YET BUT THE FORTHCOMING ANALYSIS ON IT SHOULD CONCLUDE THAT THE IMPLANTED DEVICE IS NOT DEFECTUOUS AND SHOULD CONFIRM THAT THE USER SELECTED AN IN ADAPTATED VALVE FOR THE PATIENT'S NEEDS.

    Description of Event or Problem · 1

    THE SURGEON SELECTED AND IMPLANTED A POLARIS VALVE (SPV) BUT THE PRESSURE RANGE WAS NOT ADAPTED TO THE PATIENT (TOO HIGH). THE VALVE WAS THEREFORE EXPLANTED AND ANOTHER VALVE WITH VERY LOW PRESSURE WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505 POLARIS ADJUSTABLE VALVE / 5 PRESS. POLARIS ADJUSTABLE VALVE / 5 PRESS. JXG SOPHYSA SA SPV 265180/F0835

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention