BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 24194248 · Received January 27, 2026

    Report

    Report Number
    3030198397-2026-00003
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 27, 2026
    Report Date
    January 27, 2026
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    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

    PHYSICIAN CONTACTED SENIOR CLINICAL ENGINEER (SCE) TO REPORT A PROMETRA II 20 ML PUMP THAT IS UNABLE TO COMMUNICATE WITH A PROGRAMMER ON JANUARY 22, 2026. HE REPORTS THAT HE WAS ABLE TO PERFORM AN INITIAL INQUIRY, BUT SUBSEQUENT REPEATED EFFORTS SHOWED "PUMP COMMUNICATION FAILED". SCE ASKED IF THE PHYSICIAN COULD HEAR THE AUDIBLE TONE THE PROGRAMMER MAKES WHEN ATTEMPTING TO CONNECT AND THE PHYSICIAN SAID YES. SCE THEN REQUESTED THE PHYSICIAN PERFORM A POWER CYCLE ON THE PROGRAMMER AND TO CHANGE THE BATTERIES, BUT THOSE EFFORTS WERE UNSUCCESSFUL. SCE ASKED THE PHYSICIAN TO USE ANOTHER PROGRAMMER BUT THESE EFFORTS WERE ALSO UNSUCCESSFUL. AT THIS POINT, SCE RECOMMENDED A PUMP REPLACEMENT. THE PUMP HAS ALREADY BEEN EXPLANTED, REPLACED, AND DISCARDED. NO INVESTIGATION IS POSSIBLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256395 PROMETRA II PROGRAMMABLE PUMP Pump, infusion, implanted, programmable LKK INFUSYN THERAPEUTICS, LLC 13827 25379 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention