BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 24361452 · Received February 17, 2026

    Report

    Report Number
    3004209178-2026-02557
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 28, 2025
    Report Date
    February 20, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000422608
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER DEVICE REGISTRATION INDICATED THAT THE PUMP WAS REPLACED 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 AND A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE 25MG/ML AT 2.93MG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT NOTICED AN AUDIBLE ALARM SEVERAL TIMES. BOTH CRITICAL AND NON-CRITICAL ALARMS AT VARIOUS TIMES AND DAYS. THE PATIENT¿S PUMP LOGS WERE READ AND THE PATIENT HAD MOTOR STALL OCCURRENCES AND RECOVERIES SEVERAL TIMES BETWEEN DECEMBER 28, 2025 AND IN JANUARY 31, 2026. PER THE LOGS A MOTOR STALL OCCURRED ON 2025-12-28 AT 9:11 AM AND A RECOVERY AT 9;20AM, A MOTOR STALL 2025-12-28 AT 12:02PM AND A RECOVERY AT 12:13, A MOTOR STALL 2025-12-28 AT 1:54PM AND A RECOVERY AT 2:08PM, A MOTOR STALL 2026-01-12 AT 8:56AM AND A RECOVERY AT 9:07AM, A MOTOR STALL 2026-01-22 AT 10:04 AND A RECOVERY AT 10:44AM, A MOTOR STALL 2026-01-31 AT 9:10AM AND A RECOVERY AT 11:14AM AND A MOTOR STALL 2026-01-31 AT 1:34PM AND A RECOVERY AT 3:09PM. THE PATIENT STATED THAT THERE WERE NO ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO ACTIONS OR INTERVENTIONS WERE TAKEN SO FAR. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT, AND IT WAS NOTED THAT THE HEALTHCARE PROVIDER WOULD NOT HAVE ANY FURTHER INFORMATION REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA THE COMPANY REPRESENTATIVE ON 2026-02-04 WHO REPORTED THAT THE FIRST FEW STALLS LASTED AROUND 10 MINUTES BUT THE DURATIONS ESCALATED TO A COUPLE OF HOURS BEFORE THEY RECOVERED. THE AGENT REVIEWED TYPICAL CAUSES OF MOTOR STALLS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE (REP) AND CONFIRMED WITH THE HEALTHCARE PROVIDER REPORTING THAT THE PUMP WAS REPLACED ON (B)(6) 2026. THE HOSPITAL WAS IN POSSESSION OF THE PUMP, BUT DID NOT ALLOW IT TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426170 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000422608

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention