BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 25

    MDR report key: 17330128 · Received July 14, 2023

    Report

    Report Number
    3004721439-2023-00191
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 1, 2023
    Report Date
    July 14, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION: DURING THE INVESTIGATION, NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. DURING THE PERMEABILITY TEST SOME PARTICLES WERE FLUSHED OUT. 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE PROGAV IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION. THE SHUNTASSISTANT IS OPERATING NOT WITHIN THE SPECIFIED TOLERANCES IN THE VERTICAL POSITION. AN ACCELERATED OUTFLOW OF SHUNTASSISTANT COULD BE DETERMINED IN THE VERTICAL POSITON. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS LIMITED ADJUSTABLE. BETWEEN THE PRESSURE SETTING OF 12 CMH2O AND 19 CMH20 THE VALVE IS ADJUSTABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS OPERATIONAL. HOWEVER, THE BRAKING FORCE CANNOT BE MEASURED DUE TO THE LIMITED ADJUSTABILITY OF THE VALVE. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE AN ACCELERATED OUTFLOW OF THE SHUNTASSISTANT AND A LIMITED ADJUSTABILITY OF THE PROGAV VALVE. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE FUNCTIONAL DEVIATIONS. 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) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 5 YEARS, 3 MONTHS, HEIGHT: 100 CENTIMETERS (CM), WEIGHT: 158 KILOGRAMS (KG), GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805551 PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV414T 20025735 04041906132118

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention