BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6949847 · Received October 13, 2017

    Report

    Report Number
    3010079947-2017-00146
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THE PUMP WAS SUBSEQUENTLY EXPLANTED. IT WAS NOTED THAT THE PUMP WAS FUNCTIONING FINE AND THE INFECTION WAS UNRELATED TO PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728588 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other