BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 6039673 · Received October 19, 2016

    Report

    Report Number
    3006803715-2016-00167
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    March 31, 2016
    Report Date
    September 20, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020082
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FIRST NOTED AN INCREASE IN PAIN ON (B)(6) 2016, AND THEN WENT TO THE EMERGENCY ROOM ON (B)(6) 2016 DUE TO WITHDRAWAL SYMPTOMS. HE WAS GIVEN A DOSE OF OXYCODONE, AND THEN EXPERIENCED A REDUCTION IN HIS WITHDRAWAL SYMPTOMS. A CT MYELOGRAM WAS PERFORMED AND SHOWED THAT THE PUMP WAS PERFORMING NORMALLY. AS OF 10/12/2016, THE PATIENT WAS REPORTED TO BE DOING WELL. IT WAS REPORTED THAT IT IS LIKELY THAT THE ISSUE WAS ASSOCIATED WITH THE MEDICATION AND NOT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690755 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other