BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3061706 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01303
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEPTIC DUE TO AN INFECTION. AT THE TIME OF REPORT, THE PATIENT WAS IN THE HOSPITAL. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT POSITIVE, BUT FELT THAT THE EVENT WAS UNRELATED TO THE PUMP, AS THE PUMP WAS BEING CONTINUALLY MANAGED AND WOULD BE REFILLED. THE DEVICE SYSTEM WAS INFUSING COMPOUNDED BACLOFEN.

    Description of Event or Problem · 1

    THE HCP LATER CONFIRMED THAT THE PATIENT¿S INFECTION WAS NOT RELATED TO THE DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163888 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R