BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 20

    MDR report key: 9597779 · Received January 16, 2020

    Report

    Report Number
    3004721439-2020-00020
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 31, 2020
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K120559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: RESULTS: NO TESTS HAVE BEEN PERFORMED. THE SHUNT SYSTEM WAS SENT TO US DRY (I.E. NOT SUBMERSED IN LIQUID AS RECOMMENDED). AN INVESTIGATION OF VALVES SENT IN DRY IS NOT MEANINGFUL, AS THE PRODUCT CHARACTERISTICS CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD AND THEREFORE CANNOT BE EVALUATED BY US. WE ASK FOR YOUR UNDERSTANDING THAT WE DO NOT PERFORM TESTS ON PRODUCTS SENT IN THIS WAY. IN OUR VIEW, THERE IS NO FURTHER NEED FOR REGULATORY ACTION. 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.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: UNKNOWN. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS NOT BLOCKED. THE REPORTER INDICATED THAT A POST-OPERATIVE VALVE WAS BLOCKED AND REQUIRED EXPLANTATION. PATIENT INFORMATION AND ADDITIONAL INFORMATION WERE NOT PROVIDED, HOWEVER, HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59419 PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX413T 20039116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention