BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1911796 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-83437
    Event Type
    Death
    Date Received
    November 24, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS 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 DUE TO DIABETES RELATED COMPLICATIONS. IT WAS STATED THAT THE CORONER ADVISED LIKELY THE CAUSE OF THE CUSTOMER'S DEATH WAS DIABETES-RELATED HEART FIBRILLATIONS. IT WAS STATED THAT THE CUSTOMER HAD OPEN HEART SURGERY IN (B)(6) 2009. IT WAS STATED THAT THE CUSTOMER HAD SEEN HER CARDIOLOGIST THE DAY BEFORE SHE PASSED AWAY AND WAS GIVEN A CLEAN BILL OF HEALTH. ALSO, IT WAS INDICATED THAT THE CUSTOMER HAD SURGERY IN (B)(6) FOR THE REMOVAL OF A ROD PLACED TO REPAIR A BROKEN TIBIA THAT HAD RESULTED IN A BONE INFECTION. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death