BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3171172 · Received June 14, 2013

    Report

    Report Number
    3007566237-2013-01992
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT THE CATHETER TIP IN THE BACK AND TAUGHT THE CATHETER WAS NOT AT THE RIGHT POSITION BECAUSE IT WAS PUTTING PRESSURE ON THE SPINE. IT WAS INDICATED THAT PATIENT HAD A CAT SCAN DONE THIS MORNING AND IT LOOKED LIKE THE "TUBE" WAS NOT IN THE RIGHT POSITION. IT WAS ADDED THAT PATIENT WOULD BE GETTING MRI DONE BUT NOT SURE IF IT WAS RELATED TO THERAPY. IT WAS ALSO ADDED THAT PATIENT HAD THE PAIN FOR ABOUT A YEAR AND WAS NOT SURE IF THE PAIN WAS RELATED TO THE PUMP OR PATIENT¿S BACK WAS JUST DETERIORATING. IT WAS ADDED THAT THE PAIN HAD GOTTEN CONSIDERABLY WORSE IN THE LAST FOUR OR FIVE MONTHS FROM THE DAY OF THE REPORT. THE PUMP WAS BEING USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270547 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR