BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1678437 · Received May 7, 2010

    Report

    Report Number
    3004209178-2010-81205
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 20, 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 UNKNOWN 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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE, AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS AN AUTOMOBILE ACCIDENT. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE REPORTER STATED THAT THE CUSTOMER SUFFERED A SEIZURE WHILE DRIVING, WHICH CAUSED THE ACCIDENT. IT WAS NOT KNOWN IF THE SEIZURE WAS CAUSED BY HIGH OR LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death