BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-523NAS PRDGM INSULIN SMOKE

    MDR report key: 1905852 · Received November 18, 2010

    Report

    Report Number
    3004209178-2010-83387
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY DUE TO HEART FAILURE RELATED TO DIABETES. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF DEATH. IT WAS STATED THAT THE CUSTOMER WAS FEELING WELL THE DAY BEFORE. IT WAS STATED THAT THE CUSTOMER HAD CHILLS DURING THE DAY. THE CUSTOMER WENT TO BED AND SHE DID NOT WAKE UP THE NEXT MORNING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAS PRDGM INSULIN SMOKE INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death