BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 25

    MDR report key: 18055421 · Received November 2, 2023

    Report

    Report Number
    3004721439-2023-00321
    Event Type
    Injury
    Date Received
    November 2, 2023
    Report Date
    November 2, 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: VISUAL INSPECTION DID NOT REVEAL ANY SIGNIFICANT DAMAGE, BUT DID DETECT DEFORMATION OF THE HOUSING SURFACE. MEASUREMENT OF THE PLANE PARALLELISM SHOWED A DEFORMATION WITH A VALUE OF -0.073 MM [OUTSIDE THE TOLERANCE OF 0 ± 0.02 MM]. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. DURING THE PERMEABILITY TEST BLOODY LIQUID 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 BOTH VALVES ARE NOT OPERATING WITHIN THE ACCEPTABLE TOLERANCE IN EITHER 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 DETERMINE AN ACCELERATED DISCHARGE AT THE VALVES, IN THEIR RESPECTIVE RELEVANT POSITION. THE DEPOSITS VISIBLE IN THE VALVES MAY HAVE LED TO THE CHANGE IN FLOW RATE. 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 (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 1 YEARS. WEIGHT: 11 KILOGRAMS. HEIGHT: 105 CENTIMETERS. GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158001 PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV414T 20059542 04041906132118

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female Required Intervention