BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1110894 · Received August 12, 2008

    Report

    Report Number
    3004209178-2008-00607
    Event Type
    Death
    Date Received
    August 12, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 30, 2008
    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. 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, AND THE CAUSE OF DEATH IS THOUGHT TO HAVE BEEN HYPOGLYCEMIA. IT WAS ALSO REPORTED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER'S SISTER DECLINED A REQUEST TO RETURN THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death