BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED III

    MDR report key: 23632894 · Received November 24, 2025

    Report

    Report Number
    3004209178-2025-20035
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000597023
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. PREVIOUSLY REPORTED FCA NUMBER 2182207-11-22-2024-006-C NO LONGER IS APPLICABLE AS THIS EVENT DOES NOT MEET INCLUSION IN FCA. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING DILAUDID VIA AN IMPLANTABLE PUMP FOR NONMALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN THE OFFICE WITH AN ACTIVE CRITICAL ALARM. THE ALARM HAD BEEN SOUNDING SINCE THE LAST REFILL ON (B)(6) 2025 AND THE NEXT REFILL IS NOT UNTIL (B)(6) 2026. TECH SERVICES ASSISTED IN CLEARING THE ACTIVE ALARM ON THE HOME SCREEN AND EDUCATED ON CLEARING THIS ALARM DURING REFILLS. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING DILAUDID VIA AN IMPLANTABLE PUMP FOR NONMALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN THE OFFICE WITH AN ACTIVE CRITICAL ALARM. THE ALARM HAD BEEN SOUNDING SINCE THE LAST REFILL ON 2025-10-21 AND THE NEXT REFILL IS NOT UNTIL 2026-01-27. TECH SERVICES ASSISTED IN CLEARING THE ACTIVE ALARM ON THE HOME SCREEN AND EDUCATED ON CLEARING THIS ALARM DURING REFILLS. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237133 SYNCHROMED III PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8667-20 00763000597023

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female