BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESERVOIR 3CC

    MDR report key: 2082625 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-81226
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    November 1, 2010
    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 Location
    CT, US
    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE MDR # 2032227-2011-00999 FOR INSULIN PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS UNK AT TIME OF DEATH. NO FURTHER INFO 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 H7598068

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death