BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA EDMS

    MDR report key: 3931915 · Received July 14, 2014

    Report

    Report Number
    2021898-2014-00242
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 16, 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 RETURNED PRODUCT WAS PATENT. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE TEST DUE TO A SMALL TEAR THAT WAS OBSERVED ON THE PATIENT LINE ABOVE THE ZERO REFERENCE STOPCOCK. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL EXACTA EDMS¿S ARE 100% LEAK TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A HOLE WAS FOUND IN THE PATIENT LINE TUBING OF AN EXACTA EDMS. IT WAS ALSO REPORTED THAT IT WAS POSSIBLE THAT THE HOLE WAS CREATED BY THE NURSE DURING SET-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411115 EXACTA EDMS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 207983302

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR