BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 24189755 · Received January 27, 2026

    Report

    Report Number
    3030198397-2026-00002
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    December 17, 2025
    Manufacturer
    INFUSYN THERAPEUTICS, LLC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD, DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. DEVICE HAS NOT YET BEEN RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. AS ADDITIONAL PHYSICAL INVESTIGATION WAS NOT PERFORMED ON THE DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE ALLEGED ISSUE. THIS COMPLAINT WILL BE CLOSED AND RE-OPENED IF/WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING A PATIENT'S PUMP THAT WAS SHOWING SLIGHTLY MORE MEDICATION LEFT IN THE PUMP THAN EXPECTED. THE NURSE STATED THAT THE PATIENT WAS NOT ALLEGING ANY NEGATIVE SYMPTOMS, BUT THAT THE PUMP IS SCHEDULED FOR EXPLANT ON (B)(6) 2025, SINCE THERE WERE A COUPLE MORE MLS OF MEDICATION PULLED OUT THAN WAS EXPECTED. SCE WALKED THE REPORTER THROUGH SEVERAL TROUBLESHOOTING STEPS, INCLUDING A DYE STUDY TO DETERMINE IF THERE WAS AN OCCLUSION OR A KINK. HOWEVER, THE PHYSICIAN ASSOCIATED WITH THE CASE REPORTED THAT THAT WOULD NEED TO BE PERFORMED BY THE MANAGING PHYSICIAN AND AS THE SURGEON, THEY WILL ONLY DO EITHER A REVISION OR AN EXPLANT. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254128 PROMETRA II PROGRAMMABLE PUMP Pump, infusion, implanted, programmable LKK INFUSYN THERAPEUTICS, LLC 13827 23201 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention