BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS

    MDR report key: 10313438 · Received July 23, 2020

    Report

    Report Number
    2032227-2020-151436
    Event Type
    Death
    Date Received
    July 23, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 23, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING THE CUSTOMER¿S PASSING FROM THE SOCIAL MEDIA ACCOUNT OF THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON JULY 16, 2020 STATED THE FOLLOWING - REPORTER ALLEGES: THE CUSTOMER HAD PASSED AWAY A WHILE BACK AND THE ATTORNEY HAD FILED A COMPLAINT AGAINST MEDTRONIC SINCE THE CUSTOMER WAS USING A MEDTRONIC 722 INSULIN PUMP. THERE WAS ALSO A LINK TO A VIDEO THAT ALLEGED POSSIBLE VENT BLOCKAGE. NO FURTHER INFORMATION WAS PROVIDED AND THE CUSTOMER WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779329 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O FRN-UNK-RSVR, UNOMED SET