BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.

    MDR report key: 9588815 · Received January 14, 2020

    Report

    Report Number
    3004721439-2020-00008
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 14, 2020
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANTATION: 2017. INVESTIGATION: VISUAL INSPECTION: N/A. PERMEABILITY TEST: N/A. ADJUSTMENT TEST: N/A. BRAKING FORCE AND BRAKE FUNCTION TEST: N/A. COMPUTER CONTROLLED TEST: N/A. RESULTS: THE SHUNT SYSTEM WAS SENT TO US DRY WITH DRIED-ON BLOODY RESIDUES. AN EXAMINATION OF DRY SEND VALVES IS NOT MEANINGFUL, BECAUSE THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD AND THEREFORE CANNOT BE EVALUATED OTHERWISE. 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 (B)(4). NO FURTHER ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS UNDER-DRAINING. THE REPORTER INDICATED THAT A 2 YEAR POST OPERATIVE VALVE WAS UNDER-DRAINING. PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49450 PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX435T 20032394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention