BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR

    MDR report key: 8487822 · Received April 5, 2019

    Report

    Report Number
    3004721439-2019-00086
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 30, 2019
    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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044 MANUFACTURING SITE EVALUATION: VISUAL INSPECTION - NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE PROGAV VALVE OR THE PEDIATRIC BURRHOLE RESERVOIR WERE DETECTED. PERMEABILITY TEST- THE TEST HAS SHOWN THAT BOTH THE VALVE AND RESERVOIR ARE PERMEABLE. ADJUSTMENT TEST - THE PROGAV VALVE WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. THE BRAKING FORCE/FUNCTION TEST - THE TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. RESULTS - AFTER THE ABOVE TESTS, WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND A BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OCCLUSION. THE VALVE OPERATES WITHIN THE SPECIFIED TOLERANCES. HOWEVER, IT IS POSSIBLE THAT THE DEPOSITS OBSERVED INSIDE THE VALVE COULD HAVE TEMPORARILY OCCLUDED THE SYSTEM IN THE PAST. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HC-THERAPY BY SHUNT IMPLANTS. 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.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV VALVE HAD A DRAINAGE ISSUE. A PATIENT UNDERWENT A SHUNT SYSTEM IMPLANTATION ON (B)(6) 2019. SOMETIME LATER, IT WAS NOTED THAT THE VALVE WAS NOT DRAINING. ON (B)(6) 2019, THE SHUNT WAS REPLACED DUE TO THIS MALFUNCTION. FURTHER DETAILS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279413 PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX490T 20037743

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention