BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 23426749 · Received October 30, 2025

    Report

    Report Number
    3030198397-2025-00001
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    June 24, 2025
    Report Date
    October 23, 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
    WI, US
    Reporter Occupation
    501

    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 REMAINS IMPLANTED AND WAS NOT 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

    PATIENT CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING THE EXPLANT OF THEIR IMPLANTED PUMP SCHEDULED FOR (B)(6) 2025. THE CALLER REPORTS THAT ON (B)(6) 2025, A REFILL WAS PERFORMED BY THE PHYSICIAN ASSISTANT AT THEIR TYPICAL PAIN PRACTICE. THE PATIENT REPORTS TASTING AND SMELLING METALLIC SHORTLY AFTER THE FILL AND GROWING MORE LETHARGIC WITH BACK SPASMS OVER THE NEXT TWO DAYS, LEADING TO THE FIRST OF THREE EMERGENCY ROOM VISITS OVER THE SUBSEQUENT 4 DAYS, BEGINNING ON (B)(6) 2025. UPON INQUIRY AT THE ER, NO PUMP ERRORS OR OTHER ISSUES WERE OBSERVED WITH THE PUMP. DUE TO THE NATURE OF THE SYMPTOMS, THE SCE WALKED THE CALLER THROUGH THE PROPER TECHNIQUE FOR PERFORMING REFILLS: INJECT IN 1ML, WAIT FOR ASPIRATION BACK, PUSH 5 MLS, WAIT FOR 1ML, PUSH 5ML, REPEAT UNTIL FULLY REFILLED) AND THE CALLER DESCRIBED THAT THE PA DID NOT SEEM TO FOLLOW THIS PROCEDURE. SCE THEN EXPLAINED WHAT A POCKET FILL ENTAILS AND SUGGESTED A CONFERENCE WITH THE PHYSICIAN TO DISCUSS NEXT STEPS OR TRAINING FOR REFILLS. HOWEVER, THE PATIENT INFORMED SCE THAT THE PHYSICIAN IS SET ON HAVING THE PUMP REPLACED WITH A MEDTRONIC PUMP DURING THE FOLLOWING WEEK ON (B)(6) WITH NO DESIRE TO TROUBLE SHOOT. AS OF JULY 25, 2025, THE PHYSICIAN'S OFFICE IS NOT RETURNING CALLS TO SCE AN RGA WILL BE CREATED AT THE POINT THAT SCE IS ABLE TO SPEAK TO SOMEONE AT THE PAIN PRACTICE, OR THE SURGICAL FACILITY. ON JULY 28, 2025, NURSE FROM THE FACILITY CONTACTED SCE AND PROVIDED HIM WITH THE INFORMATION TO CREATE THE RGA. AS OF (B)(6), 2025, THE EXPLANT HAS BEEN CANCELLED AND RESCHEDULED 7 TIMES AND IS CURRENTLY NOT ON A NEW SCHEDULE. ACCORDING TO THE NURSE, THE PATIENT HAS BEEN REFILLED AND IS STILL USING THE PUMP WITH NO ISSUES. IF THE EXPLANT CONTINUES, A SUPPLEMENTAL MDR WILL BE FILED. WITHOUT AN EXPLANT PROCEDURE, THIS CASE IS NOT REPORTABLE; HOWEVER, DUE TO THE LENGTH OF TIME, IT IS STILL BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342854 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK INFUSYN THERAPEUTICS, LLC 13827 23447 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R