BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 20

    MDR report key: 16914702 · Received May 11, 2023

    Report

    Report Number
    3004721439-2023-00117
    Event Type
    Injury
    Date Received
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132101
    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

    INVESTIGATION: VISUAL INSPECTION: DURING THE INVESTIGATION, SCRATCHES ON THE OUTER HOUSING OF THE VALVES AND DEPOSITS ON THE CATHETER WERE DETERMINED. FURTHERMORE, A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV VALVE COULD BE DETERMINED. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF 0,120 MM - OUTSIDE TOLERANCE (0 ± 0.02 MM). PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE VALVES OPERATE WITHIN THE ACCEPTED TOLERANCE IN BOTH POSITIONS. 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 AS WELL AS A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV. NEITHER THE DEPOSITS NOR THE DEFORMATION HAD AN EFFECT 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 SHUNT SYSTEM (#FV413T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE. 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: 16 YEARS. HEIGHT: 128 CENTIMETERS (CM). WEIGHT: 35 KILOGRAMS (KG). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829844 PROGAV WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV413T 20007547 04041906132101

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention