BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 21344164 · Received February 10, 2025

    Report

    Report Number
    MW5165813
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Report Date
    February 4, 2025
    Manufacturer
    INFUSYN THERAPEUTICS
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED PREVIOUS FLOWONIX PUMPS AND CATHETERS THAT DID NOT WORK, AS PATIENT DID NOT RECEIVE PAIN RELIEF FOR THE PAST 3 YEARS. INFORMATION INDICATES THE FLOWONIX PUMP(S) WERE REPLACED WITH A (B)(6) PUMP, FLOWONIX CATHETER IS STILL IN USE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784067 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown