BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE À PRESSION AJUSTABLE POUR DÉRIVATION DU LCR

    MDR report key: 17037746 · Received June 1, 2023

    Report

    Report Number
    3001587388-2022-22619
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    November 20, 2022
    Report Date
    June 1, 2023
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION, IT IS DIFFICULT TO DETERMINE IF THE FALL WAS THE CAUSE OF ANY DISFUNCTION (DISCONNECTION OF THE DISTAL CATHETER FOR INSTANCE) OR THE RESULT OF A DISFUNCTION. ANYWAY, THE SPVA VALVE WAS CONFORMING TO ITS SPECIFICATIONS IN THE RETURN STATE. WITH THE CURRENTLY AVAILABLE ELEMENTS, THE ANALYSIS PERFORMED BY OUR QUALITY CONTROL DEPARTMENT DID NOT UNDERLINE SOPHYSA DEVICE ABNORMALITIES THAT COULD EXPLAIN THE REPORTED UNDERDRAINAGE SYMPTOMS.

    Description of Event or Problem · 0

    74 YEAR OLD MALE HAD A NEW SOPHYSA POLARIS VALVE INSERTED ON THE (B)(6) 2022 FOR ? BLOCKAGE OF PREVIOUS SOPHYSA POLARIS VALVE THAT WAS INITIALLY INSERTED ON (B)(6) 2021. CT SCAN PRE OP (B)(6) 2022 SHOWED SLIT VENTRICLES. ON THE (B)(6) 2022 THE 74 MALE HAD A FALL AND WAS CONFUSED. CT SCAN SHOWED ENLARGED VENTRICLES. THIS 74 YO MALE WAS TAKEN BACK TO THEATRE FOR A SHUNT REVISION ON THE (B)(6) 2022. THE DISTAL CATHETER WAS TESTED AND WAS PATENT. THE VENTRICULAR CATHETER WAS DETACHED FROM THE SOPHYSA POLARIS SPVA VALVE AND WAS PATENT WITH CSF EXITING THE VENTRICULAR CATHETER FREELY. THE SOPHYSA POLARIS VALVE SPVA WAS REMOVED WITH THE SURGEON REQUESTING THAT IT BE SENT TO SOPHYSA FOR ANALYSIS. A NEW SOPHYSA POLARIS SPVA2010 WAS IMPLANTED. THERE HAVE BEEN NO FURTHER REPORTS OF ISSUES SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296300 VALVE À PRESSION AJUSTABLE POUR DÉRIVATION DU LCR VALVE À PRESSION AJUSTABLE POUR DÉRIVATION DU LCR JXG SOPHYSA SPVA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention