BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1659051 · Received April 12, 2010

    Report

    Report Number
    3004209178-2010-80978
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    March 21, 2010
    Report Date
    March 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS NATURAL CAUSES. THE CUSTOMER WAS EXPERIENCING LOW BLOOD PRESSURE AT THE TIME OF DEATH. THE NIGHT PRIOR TO THE EVENT, THE CUSTOMER WENT TO SLEEP WEARING THE INSULIN PUMP. WHEN THE CUSTOMER'S WIFE FOUND HIM THE NEXT MORNING, HE WAS NO LONGER WEARING THE INSULIN PUMP. SHE FOUND THE INSULIN PUMP UNDER SOME TOWELS IN THE BATHROOM. SHE SURMISED THAT THE CUSTOMER HAD TAKEN THE INSULIN PUMP OFF DURING THE NIGHT. THE LAST THING SHE REMEMBERS SEEING ON THE INSULIN PUMP WAS "LOW BG." THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death