BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722RNAS PRDGM INS SK EN RC

    MDR report key: 1747745 · Received June 29, 2010

    Report

    Report Number
    2032227-2010-81707
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 7, 2010
    Manufacturer
    MEDTRONIC MINIMED
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER PASSED AWAY BY DROWNING. THE CUSTOMER HAD GONE FISHING, AND EXPERIENCED HEART FAILURE WHILE HE WAS ON THE BOAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HIS DEATH, BUT IT WAS UNK WHETHER OR NOT HIS DIABETES PLAYED A PART. IT WAS ALSO STATED THAT THE CUSTOMER'S SETTINGS HAD BEEN CHANGED JUST DAYS PRIOR TO HIS DEATH. THE FAMILY AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAS PRDGM INS SK EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death