BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1721465 · Received June 8, 2010

    Report

    Report Number
    3004209178-2010-81518
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 21, 2008
    Report Date
    May 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS ALLEGED BY AN ATTORNEY THAT THE CUSTOMER WAS IN A VEHICULAR ACCIDENT, WHICH RESULTED IN THE CUSTOMER'S DEATH. IT WAS ALLEGED THAT A MALFUNCTION OF THE INSULIN PUMP CAUSED THE CUSTOMER TO LOSS CONSCIOUSNESS OR CONTROL OF HER MENTAL FACILITIES AND BODILY FUNCTIONS. THE NATURE OF THE ALLEGED MALFUNCTION WAS NOT DIVULGED. HOWEVER, IT WAS ALLEGED THAT THE MALFUNCTION WAS CAUSED BY THE DEFECTIVE DESIGN OR MANUFACTURE OF THE INSULIN PUMP AND/OR INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death