BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7001237 · Received November 3, 2017

    Report

    Report Number
    3010079947-2017-00154
    Event Type
    Death
    Date Received
    November 3, 2017
    Date of Event
    September 29, 2017
    Report Date
    October 4, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    AS A RESULT OF A MAILING TO THE PATIENT, THE PACKAGE WAS RETURNED VIA (B)(4) STATING THAT THE PATIENT WAS DECEASED. 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
    778091 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP, LKK FLOWONIX MEDICAL, INC. 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death