BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II, SMALL

    MDR report key: 2941245 · Received January 18, 2013

    Report

    Report Number
    2021898-2013-00018
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT ALSO MET THE REQUIREMENTS FOR SIPHON, PREIMPLANTATION, AND LEAK TESTING. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR REFLUX AND PRESSURE-FLOW TESTING DUE TO INTERFERENCE OF CRYSTALLINE DEBRIS WITH THE VALVE'S INTERNAL FLOW CONTROL MECHANISMS. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND/OR SIPHONING. A REVIEW OF THE MFG SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND NOT TO BE WORKING PROPERLY WHEN TESTED FOLLOWING IMPLANTATION AND ALSO THAT "WHILE THINGS" WERE OBSERVED FLOATING IN THE SUSPECT DEVICE. ACCORDING TO THE REPORT, BOTH THE PROXIMAL AND DISTAL FLOW WERE TESTED AND FUNCTIONED PROPERLY. THE REPORT STATES THAT THE VALVE WAS REPLACED AND THE FLOW WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28311 STRATA II, SMALL JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D34067

    Patients

    Seq Age Sex Outcome Treatment
    1