BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 24544279 · Received March 9, 2026

    Report

    Report Number
    MW5184836
    Event Type
    Injury
    Date Received
    March 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    INFUSYN THERAPEUTICS
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (10 MG/ML AT 2.3 MG/DAY) VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT A DYE STUDY WAS ATTEMPTED ON (B)(6) 2026 AND THE PHYSICIAN COULD NOT ASPIRATE. THE PHYSICIAN WAS CONCERNED ABOUT THE CATHETER INTEGRITY DUE TO INCREASES IN INFUSION RATES AT LAST REFILL. IT WAS NOTED THAT THE PATIENT HAD A FLOWONIX CATHETER THAT APPEARED TO BE AT THE T9 LEVEL, BUT IT WAS ATTACHED TO A MEDTRONIC PUMP CONNECTOR AND A MEDTRONIC PUMP. IT WAS UNKNOWN WHY THE FLOWONIX CATHETER WAS BEING USED WITH THE OTHER MEDTRONIC PRODUCTS. THERE WERE NO REPORTED ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN WAS SENDING THE PATIENT TO A SURGEON FOR POSSIBLE RETRY OF THE DYE STUDY AND/OR CATHETER REVISION/REPLACEMENT IF NEEDED. NO APPOINTMENT HAD YET BEEN SCHEDULED. 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
    613375 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown