BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 1843581 · Received September 20, 2010

    Report

    Report Number
    2032227-2010-82693
    Event Type
    Death
    Date Received
    September 20, 2010
    Date of Event
    April 25, 2009
    Report Date
    August 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY WHILE WEARING THE INSULIN PUMP. THE CUSTOMER'S HUSBAND FELT THAT THE DEATH MAY HAVE BEEN RELATED TO THE LOT 8 RECALL, BUT HAS NOT PROOF. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death