BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II INTRATHECAL BACLOFEN PUMP

    MDR report key: 24489859 · Received March 2, 2026

    Report

    Report Number
    MW5184598
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 17, 2026
    Report Date
    February 26, 2026
    Manufacturer
    FLOWONIX / INFUSYN THERAPEUTICS
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FLOWONIX/INFUSYS THERAPEUTICS INTRATHECAL BACLOFEN PUMP FAILED IN CLINICAL USE, WHILST IMPLANTED IN AN NHS UNITED KINGDOM PATIENT. THIS DEVICE IS CLINICALLY UNSUPPORTED BY THE COMPANY IN THE UK/EU. DEVICE EXPLANTED FROM PATIENT AND REPLACED BY MANUFACTURER SUPPORTED MEDTRONIC SYNCROMED PUMP. PUMP TO BE RETURNED TO INFUSYN FOR INVESTIGATION AS CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553222 PROMETRA II INTRATHECAL BACLOFEN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX / INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other