BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 8140463 · Received December 6, 2018

    Report

    Report Number
    3010079947-2018-00260
    Event Type
    Death
    Date Received
    December 6, 2018
    Date of Event
    March 2, 2017
    Report Date
    November 6, 2018
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4). ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE CAUSE OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT PASSED AWAY IN HOSPICE CARE. THE PATIENT'S DEATH IS UNRELATED TO PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979708 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death