BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA VALVE

    MDR report key: 17627577 · Received August 25, 2023

    Report

    Report Number
    3004721439-2023-00252
    Event Type
    Injury
    Date Received
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906133023
    PMA / PMN Number
    K161853
    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 VISUAL INSPECTION A DEFORMATION OF THE OUTER HOUSING OF THE PROSA VALVE COULD BE DETERMINED. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF -0,093 MM - OUTSIDE TOLERANCE (0 ± 0.02 MM). PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF UNDER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVE IS TESTED IN THE HORIZONTAL POSITION. THE RESULTS SHOW THAT THE VALVE OPERATES WITHIN THE ACCEPTED TOLERANCES IN THE VERTIKAL POSITION. ADJUSTMENT TEST: THE PROSA 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 VALVE, NO DEPOSITS WERE FOUND IN PROSA. TO MAKE POSSIBLE PROTEINS / DEPOSITS IN THE VALVE VISIBLE, THE PROSA WAS COLORED USING A STAINING SOLUTION. RESULT: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A DEFORMATION OF THE HOUSING SURFACE. THE DEFORMATION 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 VALVE 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 PROSA(#FV701T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. 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: 13 YEARS WEIGHT: 20 KILOGRAMS (KG). HEIGHT: 130 CENTIMETERS (CM). GENDER: MALE. SAME EVENT AS #3004721439-2023-00251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919338 PROSA VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV701T 20038095 04041906133023

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention