BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS SPVA KIT PREATTACHED B 019-10

    MDR report key: 762927 · Received August 12, 2006

    Report

    Report Number
    762927
    Event Type
    Injury
    Date Received
    August 12, 2006
    Date of Event
    August 4, 2006
    Report Date
    August 12, 2006
    Manufacturer
    SOPHYSA USA, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A VENTRICULOPERITONEAL SHUNT IMPLANTED. THE PATIENT DEVELOPED BILATERAL SUBDURAL HEMATOMAS WHICH REQUIRED BILATERAL BURR HOLES FOR DRAINAGE OF THE HEMATOMAS. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE SHUNT. THE SURGEON ATTEMPTED TO PLACE TWO OTHER SOPHYSA SHUNTS AND BOTH SHUNTS FAILED TO STOP DRAINING FLUID AT THE SET MARK OF 70 MM. IN FACT, THE FLUID COMPLETELY EVACUATED THROUGH THE SECOND VALVE. REPEATED TESTS WITH THIS VALVE FAILED TO DEMONSTRATE ANY VALVULAR COMPETENCE. THE SURGEON SUBSEQUENTLY TESTED A DIFFERENT PROGRAMMABLE VALVE AND FOUND THIS OTHER MANUFACTURER'S DEVICE TO BE COMPETENT AND STOPPED THE FLUID AT THE SET LEVEL OF 60MM. THE SURGEON IMPLANTED THE OTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS SPVA KIT PREATTACHED B 019-10 VENTRICULOPERITONEAL SHUNT JXG SOPHYSA USA, INC. * 75719/R0295

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R