BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1657156 · Received April 8, 2010

    Report

    Report Number
    3004209178-2010-80936
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 22, 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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE, 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. THE RPTR BELIEVES THE CAUSE OF DEATH WAS DIABETES RELATED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. AN AUTOPSY HAD NOT BEEN PERFORMED AT THE TIME OF THE REPORT. 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 47 YR Death