BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1132783 · Received August 21, 2008

    Report

    Report Number
    MW5008057
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    September 1, 2007
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE HAD DIABETES MELLITUS FOR 54 YEARS -1954- CONTROLLED WITH INSULIN SINCE DIAGNOSIS. HAVE WORN INSULIN PUMP SINCE EARLY 1980'S WITH GOOD CONTROL, COMFORT AND HEALTH. RECEIVED A PUMP UPGRADE IN 2007 TO THE MEDTRONIC PARADIGM. SHORTLY THEREAFTER, I STARTED HAVING VAGUE SYMPTOMS AT NIGHT: SLEEPLESSNESS, BACK PAINS, CHILLS AND STOMACH ACHES. THE INTENSITY OF THE SYMPTOMS INCREASED AND WITHIN SEVERAL MONTHS, I WAS WAKEFUL FOR AT LEAST AN HOUR EVERY NIGHT, I WOULD MOVE TO A RECLINER OR OTHER SITTING POSITION TO KEEP MY STOMACH COMFORTABLE AND I NEEDED A HEATING PAD TO WARM UP ENOUGH TO RESUME SLEEP. I HAD ALSO BEGUN EXPERIENCING RESTLESS LEG SYNDROME AND MY BODY BEGAN QUAKING INSIDE. BY SPRING OF 2008, I WAS EXPERIENCING ALL OF THE ABOVE SYMPTOMS VERY SEVERELY. I WOULD WAKE UP ABOUT 12:30-1 AM AND BE AWAKE UNTIL ABOUT 5 AM. I CONTINUED TO REPORT THESE SYMPTOMS TO MY ENDOCRINOLOGIST AND MY PRIMARY CARE PHYSICIAN. I EVEN SOUGHT TWO OTHER MEDICAL DOCTORS BUT NOBODY CAME UP WITH ANY REASON WHY I WAS EXPERIENCING THESE SYMPTOMS, SO THEY BASICALLY IGNORED THE PROBLEM. ONE NIGHT IN 2008, I REALIZED I WAS GETTING ELECTRIC SHOCKS. THEN IT DAWNED ON ME THAT I WAS WEARING AN INSULIN PUMP THAT REPROGRAMMED ITSELF EVERY NIGHT AT 12 AM. I RETURNED THAT PUMP AND GOT A REPLACEMENT AND HAVE HAD NO PROBLEMS SINCE. I NEED TO KNOW IF THERE ARE OTHERS WHO HAVE HAD THIS EXPERIENCE AND WHAT WAS THEIR OUTCOME. I'D LIKE TO PREVENT OTHERS FROM HAVING IT HAPPEN TO THEM. DOSE OR AMOUNT: 30 U HUMALOG PER DAY. DATES OF USE: 2006-2008, APPROX. 2 YEARS. DIAGNOSIS OR REASON FOR USE: TYPE I DIABETES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED MMT-522LNAS A000114248

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R