BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 25

    MDR report key: 16029262 · Received December 21, 2022

    Report

    Report Number
    3004721439-2022-00392
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 21, 2022
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132118
    PMA / PMN Number
    K103003
    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: A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV VALVE WAS OBSERVED THROUGH THE VISUAL INSPECTION. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF -0,047MM THE HOUSING MEMBRANE IS OUTSIDE TOLERANCE (0 ± 0.02 MM). PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT BOTH VALVES ARE PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF OVER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE RESULTS SHOW THAT THE PROGAV IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION. ALSO, THE SHUNTASSISTANT IS OPERATING WITHIN THE SPECIFIED TOLERANCES IN THE VERTICAL POSITION. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS 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. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. TO MAKE THE PROTEINS / DEPOSITS IN THE SHUNT SYSTEM MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE DEPOSITS. THE DEPOSITS HAD NO AFFECT TO THE TECHNICAL PROPERTIES AT THE TIME OF THE INVESTIGATION. THE CAUSE OF THE AFOREMENTIONED FUNCTIONAL IMPAIRMENT IS NOT KNOWN TO US AT THE TIME OF THE EXAMINATION. 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 PROGAV SHUNTSYSTEM (PART # FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND WAS NON-ADJUSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED 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
    1631658 PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV414T 20055364 04041906132118

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Required Intervention