BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER

    MDR report key: 10373032 · Received August 6, 2020

    Report

    Report Number
    3004721439-2020-00149
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 19, 2020
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION ARE PROVIDED WITH RETURNED PRODUCT. THE SERIAL NUMBER INDICATED A DIFFERENT DELIVERY LOT AS THE PREVIOUS ONE. ADDITIONAL DATA ABOUT THE PATIENT WERE TRANSMITTED. THESE HAVE BEEN UPDATED IN THIS FOLLOW UP REPORT. D4 MODEL: FX440T. D10 DEVICE RETURNED BY MANUFACTURER 08/04/2020. G5 PMA/510(K) NUMBER: K161853. IN ADDITION, THE PRODUCT HAS NOW BEEN FINALLY INVESTIGATED. INVESTIGATION RESULTS: VISUAL INSPECTION: NO DEVIATIONS ARE DETECTED. PERMEABILITY TEST: THE TEST SHOWED THAT THE PROGAV 2.0 IS PERMEABLE. COMPUTER CONTROLLED TEST: THE TEST HAS SHOWN THE OPENING PRESSURE OF THE PROGAV 2.0, AT A REFERENCE FLOW RATE OF 20 ML/HR IN A HORIZONTAL POSITION, TO BE 1.39 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 7 CMH2O ± 3 CMH2O. AN APPLIED PRESSURE OF 1.39 CMH2O, WITH THE DEVICE IN THE HORIZONTAL POSITION IS EXPECTED TO HAVE A RESULTANT OPENING PRESSURE OF 7 CMH2O ± 3 CMH2O. ADDITIONAL TESTING DID NOT SIGNIFICANTLY CHANGE THE RESULTS. ACCORDING TO OUR RESULTS, WE CAN OBSERVE A PRESENCE OF AN OVER- DRAINAGE. ADJUSTABILITY TEST: THE PROGAV 2.0 WAS FOUND TO BE FOUND TO BE NON-ADJUSTABLE WITHIN THE SPECIFIED RANGE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE TEST INDICATES THAT THE BRAKE FUNCTION OF THE PROGAV 2.0 IS PRESENT DUE TO THE NON-ADJUSTABILITY OF THE VALVE, AN INVESTIGATION OF THE BRAKING FORCE WAS NOT POSSIBLE. INTERNAL INSPECTION OF PRODUCT: AFTER DISMANTLING OF THE VALVE, CLEARLY DEPOSITS WERE FOUND IN PROGAV 2.0. RESULTS: BASED ON OUR INVESTIGATION, WE ARE NOT ABLE TO SUBSTANTIATE THE CLAIM OF "UNDER-DRAINAGE" BUT WE CONFIRM THE PRESENCE OF "NON-ADJUSTABILITY" AND "OVER- DRAINAGE". WE ARE ASSUMING THAT THE DEPOSITS DETECTED WITHIN THE VALVE HAVE CAUSED THE FUNCTIONAL IMPAIRMENT. DEPOSITS CAUSED BY NATURAL SUBSTANCES IN THE CEREBROSPINAL FLUID, SUCH AS PROTEIN, BLOOD OR TISSUE PARTICLES, ARE AMONG THE KNOWN AND UNAVOIDABLE RISKS AND SIDE EFFECTS OF 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. FROM OUR POINT OF VIEW, NO FURTHER REGULATORY ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A PROGAV 2.0. THE PATIENT WAS IMPLANTED WITH THE SHUNT, THE PRODUCT FAILED TO REGULATE PRESSURE AND THE PATIENT DEVELOPED SYMPTOMS OF HIGH INTRACRANIAL PRESSURE. AFTER TWO MONTHS THE DOCTOR REMOVED THE SHUNT AND REIMPLANTED A NEW PRODUCT. PATIENT INFORMATION: AGE: (B)(6) YEARS. WEIGHT: (B)(6). HIGHT: 178 CM. GENDER: UNKNOWN. IMPLANTATION: (B)(6) 2020. EXPLANTATION: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838820 PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX440T 20037830

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention