BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 1721467 · Received June 8, 2010

    Report

    Report Number
    3004209178-2010-81494
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 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 REPORTED THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS DIABETIC COMA. IT WAS NOT KNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. TWO DAYS PRIOR TO THE EVENT, THE CUSTOMER WAS AT A GRADUATION CEREMONY AND SOME DRINKING WAS GOING ON. THE NEXT MORNING, THE CUSTOMER WAS NOT FEELING WELL AND HIS FATHER URGED HIM TO GO TO THE HOSPITAL. HOWEVER, THE CUSTOMER REFUSED TO GO TO THE HOSPITAL. THE NEXT MORNING, THE CUSTOMER'S FATHER FOUND HIM DEAD. MORE THAN FOUR ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER'S DOCTOR AND NEXT OF KIN TO REQUEST THE RETURN OF THE INSULIN PUMP, BUT THE CUSTOMER'S NEXT OF KIN'S PHONE NUMBER WAS OUT OF SERVICE AND THE NUMBER GIVEN FOR THE CUSTOMER'S DOCTOR WAS WRONG. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death