BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 2631599 · Received June 21, 2012

    Report

    Report Number
    MW5025938
    Event Type
    Death
    Date Received
    June 21, 2012
    Report Date
    June 21, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CLIENT'S DECEASED. RECEIVED A "NOTICE" FROM MEDTRONIC REGARDING THE RECALL OF "LOT 8" QUICK-SET INFUSION SETS AFTER HER DEATH ON (B)(6) 2009. SHE WAS USING ONE OF THE SETS AT THE TIME OF HER DEATH, FOR HER DIABETES MELLITUS, TYPE I. THE AUTOPSY LISTS THE CAUSE OF DEATH AS: "ENDOCARDIAL LEFT VENTRICULAR FIBROELASTOSIS, POSSIBLY IN ASSOCIATION WITH CARDIA DYSRHYTHMIA AND WITH DIABETIC KETOACIDOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LOT 8, QUICK SET INFUSION SETS FPA MEDTRONIC 8

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death