BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUET EDMS, INTERLINK

    MDR report key: 3060465 · Received April 11, 2013

    Report

    Report Number
    2021898-2013-00135
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    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 MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT MEDICATION WAS INJECTED INTO THE PROXIMAL STOPCOCK OF THE DEVICE IN ERROR, AND THAT THE MEDICATION WAS REMOVED BEFORE IT REACHED THE PATIENT. ACCORDING TO THE REPORT, THE PATIENT WAS "FINE" FOLLOWING THE EVENT AND DID NOT SUFFER ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154610 DUET EDMS, INTERLINK JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR