BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSION SYSTEM

    MDR report key: 2010401 · Received March 2, 2011

    Report

    Report Number
    MW5019658
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A MEDTRONIC INFUSION PUMP. IN 2008, THE PUMP WAS REPLACED DUE TO MALFUNCTION AFTER 4 YEARS. I HAVE RECENTLY LOST (B)(6) AND THE DR SAYS THE MORPHINE IS EATING MY MUSCLE MASS. I FEEL AWFUL AND I CANNOT SLEEP. I HAVE NO ENERGY AND MY VITAMIN D IS LOW PLUS MY POTASSIUM IS LOW. IN ADDITION, MY TESTOSTERONE LEVELS ARE VERY LOW. I CANNOT WORK AND HAVE NO STAMINA. CONCENTRATION IS ALMOST IMPOSSIBLE. IT IS VERY HARD TO GET OUT OF BED. COULD ANY OF THIS BE ATTRIBUTED TO THE RECENT MEDTRONIC RECALL OF THE DRUG INFUSION PUMP. THE PUMP WAS INITIALLY INSTALLED 7 YEARS AGO. WHAT SHOULD I DO? DR HAS SAID NOTHING. JUST TOLD ME I MUST BE FEELING BAD AS I AM OLD. ALSO NOTICED OXYGEN LEVELS ARE STARTING TO DROP. I AM NOT CONFINED TO MY HOME AND MY BED. SLEEP IS ALMOST IMPOSSIBLE. THANK YOU, (B)(6). I SAW A RECALL DATE OF 01/2011 FOR POCKETS DEVELOPING FROM PUMP OR INJECTION. DR HAS NOT NOTIFIED ME. DO NOT FEEL WELL AND THINK THIS MIGHT BE RELATED. LOST (B)(6) IN THE LAST 9 MONTHS. DR SAID MORPHINE IS WASTING MUSCLE MASS. CLASS 1 RECALL IN JAN. I HAVE NOT BEEN NOTIFIED. MY DR IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSION SYSTEM DRUG INFUSION SYSTEM 617037 LKK MEDTRONIC 8637-40 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention| S