BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 25

    MDR report key: 16507394 · Received March 8, 2023

    Report

    Report Number
    3004721439-2023-00038
    Event Type
    Injury
    Date Received
    March 8, 2023
    Report Date
    March 8, 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

    VISUAL INSPECTION: DURING THE INVESTIGATION NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING THE VISUAL INSPECTION, BUT THE MEASUREMENT OF THE PLANE PARALLELISM HAS REVEALED WITH A VALUE OF -0.050 MM [OUTSIDE THE TOLERANCE OF 0 ± 0.02 MM] A DEFORMATION. 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 BOTH VALVES ARE NOT OPERATING WITHIN THE ACCEPTABLE TOLERANCE IN THEIR RELEVANT POSITION. AN ACCELERATED OUTFLOW OF BOTH VALVES COULD BE DETERMINED. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS NOT 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 NON-ADJUSTABILITY OF THE VALVE. 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 DETECT ACCELERATED OUTFLOW, NON-ADJUSTABILITY, AND DEFORMATION ON THE BODY OF THE PROGAV, AT THE TIME OF OUR INVESTIGATION, ON THE VALVE. THE CAUSE OF THE DETECTED MALFUNCTIONS COULD BE THE DEPOSITS FOUND. 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 (PART # FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE OPERATING IN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES WERE EXPERIENCED. 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: 18 YEARS. HEIGHT: 185 CENTIMETERS (CM). WEIGHT: 110 KILOGRAMS (KG). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735804 PROGAV WITH SHUNTASSISTANT 25 HYDROCHEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV414T 20054401 04041906132118

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention