BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 15137276 · Received August 1, 2022

    Report

    Report Number
    3001587388-2022-22308
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    May 30, 2022
    Report Date
    August 1, 2022
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPV-SX WAS IMPLANTED ON (B)(6) 2020. TESTS BEFORE IMPLANTATION WERE CONFORMING. ON (B)(6) 2022, THE LOWEST SET PRESSURE WAS SET AT 30 MMH2O. THE DOCTOR INFORMED US THAT THE PATIENT WAS SHOWING SYMPTOMS OF VENTRICULAR ENLARGEMENT, BUT HIS CONDITION WAS STABLE. THESE SYMPTOMS INDICATE AN UNDERDRAINAGE AND THE DEVICE WAS SUSPECTED TO HAVE MALFUNCTIONED. THE PATIENT WAS, HOWEVER, REOPERATED ON A LATER DATE AND THE VALVE WAS CHANGED TO HAKIM. THE REMOVED VALVE WAS ALREADY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287794 SOPHYSA SPV-SX JXG SOPHYSA SPV-SX E0284

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other