BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PATIENT THERAPY CONTROLLER

    MDR report key: 6074494 · Received November 2, 2016

    Report

    Report Number
    3006803715-2016-00166
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 6, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL INSPECTION AND SIMULATED USE TESTING. THE REPORTED ISSUE WAS NOT CONFIRMED AS IT COULD NOT BE REPRODUCED IN A CONTROLLED ENVIRONMENT. GIVEN THE RESULTS OF THE INVESTIGATION, THE LIKELY CAUSE OF THE ISSUE IS DUE TO ELECTROMAGNETIC INFERENCE FROM THE CHARGING OF THE STIMULATOR. CORRECTED G8 PER REQUEST OF FDA, DATED 10/SEP/2020. INTERNAL COMPLAINT NUMBER: COMPLAINT- (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT DELIVER A BOLUS USING THE PATIENT THERAPY CONTROLLER (PTC) WHILE CHARGING HER STIMULATOR. THE STIMULATOR IS IMPLANTED ON THE SAME SIDE AS THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725071 PROMETRA PATIENT THERAPY CONTROLLER INFUSION PUMP PROGRAMMER LKK FLOWONIX MEDICAL, INC 12860

    Patients

    Seq Age Sex Outcome Treatment
    1