BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA EDMS

    MDR report key: 3961537 · Received July 28, 2014

    Report

    Report Number
    2021898-2014-00265
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS THE USER TO ENSURE THAT ALL CONNECTIONS ARE TIGHT AND LEAK-FREE BEFORE USE. (B)(4).

    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 TO MEDTRONIC NEUROSURGERY THAT THE LUER CONNECTOR UNSCREWED FROM THE PATIENT LINE STOPCOCK ON AN EXACTA EDMS THREE DAYS AFTER IT HAD BEGUN USE. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT HARMED AND HAS SINCE BEEN DISCHARGED OUT OF THE ICU TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437609 EXACTA EDMS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 208093466

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR