BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6159517 · Received December 9, 2016

    Report

    Report Number
    3006803715-2016-00195
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED IN THIS REPORT. CORRECTED G8 PER REQUEST OF FDA, DATED (B)(6) 2020. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROVIDER REPORTED THAT THE REPORTED EVENT INVOLVED A MEDTRONIC SYNCHROMED PUMP, NOT A FLOWONIX PROMETRA II PUMP. ADDITIONALLY, THE EVENT OCCURRED IN (B)(6) 2011, WHEN THE PATIENT'S SYNCHROMED PUMP WENT INTO "SAFE MODE" AFTER PASSING THROUGH AIRPORT SECURITY. THE PATIENT HAS HAD NO ISSUES WITH THEIR CURRENT PROMETRA II PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY EXPERIENCED DIZZINESS AND WITHDRAWAL AT AN AIRPORT. THE PATIENT LATER WENT TO HIS PAIN MANAGEMENT PHYSICIAN, WHO PERFORMED A PUMP RESET PROCEDURE. THE PATIENT REPORTED THAT HE FELT FINE AFTERWARDS. THE PAIN MANAGEMENT FACILITY WAS CONTACTED FOR ADDITIONAL INFORMATION, BUT HAD NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813943 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other