BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT KIT, ULTRA SMALL, MEDIUM PRESSURE

    MDR report key: 3102007 · Received May 3, 2013

    Report

    Report Number
    2021898-2013-00170
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT, AND MET THE REQUIREMENTS FOR REFLUX, LEAK, AND PREIMPLANTATION TESTING. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LAB PERSONNEL. HOWEVER, THE VALVE DID NOT MEET THE REQUIREMENTS FOR PRESSURE-FLOW TESTING DUE TO THE PRESENCE OF CRYSTALLINE DEBRIS WITHIN THE DEVICE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND/OR SIPHONING. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT FLUID WAS ABLE TO FLOW IN THE WRONG DIRECTION THROUGH THE VALVE WHEN IT WAS TESTED PREOPERATIVELY. NO ADVERSE IMPACT OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195083 SHUNT KIT, ULTRA SMALL, MEDIUM PRESSURE JXG MEDTRONIC NEUROSURGERY D13043

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR