BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6927904 · Received October 8, 2017

    Report

    Report Number
    3010079947-2017-00143
    Event Type
    Death
    Date Received
    October 8, 2017
    Date of Event
    March 7, 2017
    Report Date
    September 8, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S FAMILY MEMBER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT'S DEATH IS RELATED TO PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707456 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death