BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE PLUS SYS W/CONTROL RESERVOIR

    MDR report key: 15811071 · Received November 16, 2022

    Report

    Report Number
    3004721439-2022-00346
    Event Type
    Injury
    Date Received
    November 16, 2022
    Date of Event
    October 13, 2022
    Report Date
    November 16, 2022
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906500483
    PMA / PMN Number
    K192266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: SCRATCHES ON THE M.BLUE, OTHERWISE NO ABNORMALITIES. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVES ARE PERMEABLE. ADJUSTMENT TEST: THE M.BLUE AND PROGAV 2.0 WERE TESTED AND ARE ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF UNDER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE INVESTIGATION HAS SHOWN THAT THE M.BLUE OPERATES WITHIN THE TOLERANCE IN THE VERTICAL POSITION BUT IN THE HORIZONTAL POSITION COULD BE DETERMINED A SLOWER OUTFLOW. THE PROGAV 2.0 OPERATES WITHIN THE TOLERANCE IN THE HORIZONTAL POSITION. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. RESULTS: FOR THE SAKE OF THOROUGHNESS AND TRANSPARENCY, WE WOULD LIKE TO POINT OUT THAT A PERMEABILITY TEST WAS ALREADY CARRIED OUT AFTER THE REVISION AT THE HOSPITAL. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A SLOWER OUTFLOW AND DEPOSITS IN THE SHUNT SYSTEM. THE DEPOSITS COULD BE THE CAUSE FOR FUNCTIONAL IMPAIRMENT. PROTEINS IN THE CEREBROSPINAL FLUID CAN INFLUENCE THE FUNCTION TEMPORARILY AND ARE KNOWN SIDE EFFECTS IN HYDROCEPHALUS THERAPY. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A M.BLUE PLUS (PART # FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374423 M.BLUE PLUS SYS W/CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX824T 20057115 04041906500483

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male Required Intervention