BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-715LNAB PRDGM INS V2.1 BL EN

    MDR report key: 1221463 · Received November 3, 2008

    Report

    Report Number
    2032227-2008-01899
    Event Type
    Death
    Date Received
    November 3, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER PASSED AWAY. THE CUSTOMER'S MOTHER STATED THAT SHE FOUND THE CUSTOMER UNRESPONSIVE AND HE WAS HOSPITALIZED PRIOR TO HIS PASSING. THE CUSTOMER WAS GETTING HOME DIALYSIS AND WAS ALONE WHEN HE PASSED AWAY. THE CAUSE OF DEATH WAS NOT KNOWN AT THE TIME OF THE REPORT, BUT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO HIS DEATH, THE CUSTOMER NOTED IN HIS DAILY DIALYSIS JOURNAL THAT THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER'S MOTHER HAD REMOVED THE BATTERY FROM THE INSULIN PUMP BECAUSE IT WAS BEEPING WHEN SHE FOUND IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death