BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 3568416 · Received January 6, 2014

    Report

    Report Number
    MW5033762
    Event Type
    Death
    Date Received
    January 6, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 3, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN MEDTRONIC MINIMED SUBCUTANEOUS INSULIN PUMP WAS PLACED (PRESUMEDLY BY PT; UNCONFIRMED) THE CATHETER TIP KINKED SUCH THAT IT NEVER PENETRATED THE SKIN. IT APPEARS THAT DRUG CONTINUED TO FLOW (ABSORBED BY ADHESIVE PAD) AND PUMP ALARM FOR BLOCKAGE WAS THEREFORE NOT TRIGGERED. PT WAS FOUND DEAD IN RESIDENCE. REASON FOR USE: INSULIN DEPENDENT DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8249 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death