BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 4120659 · Received September 19, 2014

    Report

    Report Number
    4120659
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 2, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT HAS A HISTORY OF INTRACTABLE SPASTICITY WHO HAS BEEN TREATED WITH AN INTRATHECAL PUMP. SHE DID VERY WELL WITH THIS, BUT UNFORTUNATELY HAS HAD A LOSS OF EFFICACY. A ROTOR TEST WAS NORMAL, BUT A DYE TEST COULD NOT BE DONE DUE TO NO FLOW IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583154 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION N/A N289686002

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR