BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR

    MDR report key: 8705800 · Received June 17, 2019

    Report

    Report Number
    3004721439-2019-00150
    Event Type
    Injury
    Date Received
    June 17, 2019
    Report Date
    November 7, 2019
    Manufacturer
    CHRISTOPHER METHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A2, A4, D4, G1, H4 HEIGHT: 155CM. INVESTIGATION: VISUAL INSPECTION: NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE SYSTEM WAS DETECTED DURING THE VISUAL INSPECTION. PERMEABILITY TEST A PERMEABILITY TEST HAS INDICATED THAT THE PROGAV 2.0 SHUNT SYSTEM IS PERMEABLE. ADJUSTMENT TEST THE PROGAV 2.0 VALVE 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. RESULTS FIRST, WE PERFORMED A VISUAL INSPECTION OF THE PROGAV 2.0 SHUNTSYSTEM. NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE SYSTEM WAS DETECTED. NEXT WE TESTED THE PERMEABILITY OF THE SYSTEM. THE TEST RESULTS SHOW THAT THE COMPLETE SYSTEM IS PERMEABLE. TO ENSURE THAT THE PROGAV 2.0 VALVE IS ADJUSTABLE WE TRIED TO ADJUST THE VALVE FROM 0CMH2O TO 20 CMH2O AND DOWN AGAIN IN INCREMENTS OF 5 CMH2O. THE VALVE WAS ADJUSTABLE TO ALL SETTINGS. THE RESULTS SHOW THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. THE PROGAV 2.0 VALVE OPERATES AS EXPECTED AND MET ALL SPECIFICATIONS. FINALLY, 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 NON-ADJUSTABILITY. AT THE TIME OF OUR INVESTIGATION, THE PROGAV 2.0 COULD BE ADJUSTED TO ALL SPECIFIED SETTINGS. THIS IS LIKELY DUE TO THE DEPOSITS OBSERVED INSIDE THE VALVES. 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. IMPLANTED DATE. UNKNOWN, EXPLANTED DATE: UNKNOWN. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE SETTINGS OF THE SHUNT SYSTEM COULD NOT BE CHANGED AND REMAINED AT 10 CM H2O. TESTING DONE WHILE STILL IMPLANTED INDICATED THAT CSF FLOW WAS NORMAL. AS A RESULT OF THE PRESSURE SETTING DIFFICULTY, THE SHUNT WAS EXPLANTED FROM THE PATIENT. DATES OF IMPLANT AND EXPLANT NOT PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: A CONSULTANT SURGEON COMMENTED THAT THIS SITUATION "MAY BE A WIFI HEADPHONE ISSUE." NO OTHER CASE DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499062 PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPHER METHKE GMBH & CO. KG FX352T 20029911

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention