BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC MINIMED INFUSION PUMP

    MDR report key: 7352117 · Received March 19, 2018

    Report

    Report Number
    MW5075933
    Event Type
    Death
    Date Received
    March 19, 2018
    Report Date
    March 6, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    FOUND HER DECEASED (B)(6) 2018 AFTER GOING TO CHECK ON HER WHEN SHE DID NOT ANSWER THE PHONE. CALLED MEDTRONIC ON 01/12/2018 TO SEE IF PUMP WAS LEASED OR PURCHASED. (B)(6) STARTED ASKING QUESTIONS: SERIAL #, WAS SHE WEARING IT AT TIME OF DEATH, ETC. THEN SAID I'D HAVE TO SEND IT BACK FOR FAILURE ANALYSIS AND SAID IT MAY RENDER PUMP UNUSABLE. NEVER EVEN GAVE THAT A THOUGHT. MY DAUGHTER CONTACTED (B)(6). MED. BOARD AFTER HER DOC REFUSED TO DOWNLOAD PUMP'S DATA AND WAS GIVEN A CONTACT NAME AND NUMBER OF FIRM WHO HAD A MEDTRONIC EXPERT. EXPERT SAID PUMP STOPPED COLLECTING DATA ON (B)(6) 2018 AT APPROXIMATELY 3:30 PM AND WAS MOST LIKELY CAUSE OF /OR CONTRIBUTED TO HER DEATH BUT WOULD BE DIFFICULT TO PROVE IN COURT. I HAD PURCHASED NEW BATTERIES FOR HER ON THURSDAY (B)(6) 2018 AND WAS THERE WHEN SHE PUT A NEW BATTERY IN. THE PUMP HAD THE USUAL INFO DISPLAYED ACROSS THE TOP BUT NO ALERT IN THE MAIN AREA. DID YOU REPORT THIS PROBLEM TO THE COMPANY THAT MAKES THE PRODUCT: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194568 MEDTRONIC MINIMED INFUSION PUMP MEDTRONIC MINIMED INFUSION PUMP LZG MEDTRONIC IPX7 REF MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death