BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC BURR HOLE VALVE

    MDR report key: 8170707 · Received December 17, 2018

    Report

    Report Number
    2021898-2018-00566
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    October 20, 2018
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169975781
    PMA / PMN Number
    K082127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR VALVE FLUX, REFLUX, LEAK, PREIMPLANTATION AND PRESSURE-FLOW TESTING. THEREFORE, THE NATURE OF THE COMPLAINT COULD NOT BE REPLICATED BY LABORATORY PERSONNEL. THERE WAS PROTEINACEOUS DEBRIS NOTED WITHIN THE EXTERIOR OF THE VALVE. THE OUTLET OF THE VALVE WAS DISCOLORED. IT IS UNKNOWN HOW OR WHEN THIS DISCOLORATION OCCURRED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAINAGE VALVE HAD POOR ELASTICITY. THE VALVE WAS NEVER IMPLANTED AND THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE VALVE DID NOT FUNCTION WELL AND THERE WAS NO FLOW THOUGH THE VALVE. IT WAS UNKNOWN WAS CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011437 STRATA NSC BURR HOLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 42335 E41986 00643169975781

    Patients

    Seq Age Sex Outcome Treatment
    1