BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER

    MDR report key: 17732045 · Received September 12, 2023

    Report

    Report Number
    3004721439-2023-00261
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 12, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906137472
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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 2.0 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. RESULTS : IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT SENT IN WAS NOT SUBMERGED IN LIQUID AT THE TIME OF DELIVERY. THE TESTING OF DRY VALVES IS ONLY OF LIMITED VALUE. THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD. DESPITE THIS, WE HAVE EXAMINED THE VALVE. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE AN ACCELERATED OUTFLOW AND ADJUSTMENT DIFFICULTIES. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE FUNCTIONAL DEVIATIONS. ORGANIC MATERIAL (E.G. BLOOD, PROTEIN) 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 2.0 SHUNTSYSTEM (#FX442T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 7 YEARS, 3 MONTHS. HEIGHT: 118 CENTIMETERS. WEIGHT: 16 KILOGRAMS. GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826589 PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX442T 20036010 04041906137472

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention