BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4162918 · Received October 8, 2014

    Report

    Report Number
    3006803715-2014-00032
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 6, 2013
    Report Date
    September 12, 2014
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT DEVELOPED AN INFECTION AT THE BACK INCISION SOON AFTER THE DEVICE WAS IMPLANTED. THE PT WAS HOSPITALIZED, GIVEN ANTIBIOTICS AND THE PUMP WAS EXPLANTED AND DISCARDED ON (B)(6) 2013. THERE WAS NO PRODUCT ISSUE REPORTED FOR THE PUMP. THE PT HAD A NEW PUMP IMPLANTED ON (B)(6) 2014 AND HAS NOT HAD ANY ISSUES SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631544 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O