BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT KIT, ULTRA SMALL, MEDIUM PRESSURE

    MDR report key: 3012881 · Received March 1, 2013

    Report

    Report Number
    2021898-2013-00076
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS 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 FLUID WAS NOT ABLE TO FLOW THROUGH THE VALVE DURING PRE-OPERATIVE TESTING. ACCORDING TO THE REPORT, BOTH OF THE CATHETERS FROM THE SYSTEM WERE USED WITH A CONNECTOR TO COMPLETE THE SURGERY. THE REPORT STATES THAT THE PT WAS STABLE FOLLOWING TO THE PROCEDURE AND SEEMED TO BE IMPROVING. NO ADVERSE IMPACT WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90155 SHUNT KIT, ULTRA SMALL, MEDIUM PRESSURE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D13829

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO