BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESERVOIR 3CC

    MDR report key: 2072466 · Received April 22, 2011

    Report

    Report Number
    3004209178-2011-81218
    Event Type
    Death
    Date Received
    April 22, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. MEDWATCH 1 OF 3 (INSULIN PUMP): 2032227-2011-00998. MEDWATCH 2 OF 3 (INFUSION SET): 2032227-2011-01042.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THE DEATH OF HER DAUGHTER. CAUSE OF DEATH WAS REPORTED AS UNKNOWN. CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HER DEATH. CUSTOMER'S MOTHER ALSO REPORTED THAT THE RESERVOIR WAS HALF FULL AND THAT THE CUSTOMER HAD AN MRI PROCEDURE THE DAY BEFORE SHE PASSED AWAY AND CUSTOMER WAS WEARING THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death