BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 24470690 · Received February 27, 2026

    Report

    Report Number
    3004209178-2026-03570
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    November 9, 2021
    Report Date
    February 27, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000422608
    PMA / PMN Number
    P860004
    Removal / Correction Number
    2182207-01-24-2025-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: TM90T0; LOT/SERIAL# (B)(6) PRODUCT TYPE: ACCESSORY; PRODUCT ID: A820; LOT/SERIAL# UNKNOWN. PRODUCT TYPE: SOFTWARE. PRODUCT ID: HH9020TDD; LOT/SERIAL# (B)(6). SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A820; SERIAL/LOT #: UNKNOWN. 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 PATIENT WITH AN IMPLANTABLE PUMP. IT WAS REPORTED THAT STARTING TODAY SHE WENT TO USE HER PERSONAL THERAPY MANAGER (PTM) AND SHE WAS NOT ABLE TO CONNECT THE HANDSET TO COMMUNICATOR. THE PATIENT TRIED CLOSING ALL APPS, TURNING BLUETOOTH OFF AND ON, TURNING LOCATION OFF AND ON AND THE ISSUES STILL PERSISTED. THE PATIENT ALSO GOT CODE 389 STATING THE COMM MANAGER WAS NOT STARTED CORRECTLY WHILE ON THE CALL SO THE AGENT CONFERENCED IN HEALTH CARE INFORMATION TECHNOLOGY (HCIT) TO RESET THE COMM MANAGER AND POWER CYCLE THE HANDSET. FROM THERE THE HANDSET WAS ABLE TO CONNECT TO THE COMMUNICATOR AND DELIVER THE BOLUS. THE PATIENT STATED THEY WERE IN PAIN DUE TO NOT BEING ABLE TO BOLUS FOR 5 HOURS. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND IT WAS REPORTED THEY WERE EXPERIENCING THE SAME ISSUE AGAIN. THE PATIENT PROVIDED SERVICE CODE 389. THE PATIENT TRIED RESETTING THE COMMUNICATOR AND HANDSET. THE PATIENT CLAIMED THE BLUETOOTH WAS TURNING ON AND OFF WHEN IT WAS CHECKED FROM THE PULL DOWN MENU ON THE SAMSUNG. AGENT WARM TRANSFERRED PATIENT TO HEALTHCAREIT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTED THAT THEY CONTINUED TO GET SERVICE CODE 156 (APPLICATION RESTARTING DUE TO SYSTEM ERROR) AND 389 (CONNECTION INTERRUPTED ¿ COMM MANAGER NOT STARTED CORRECTLY) EVERY TIME THEY TRIED TO BOLUS. THE PATIENT ALSO STATED THAT THE HANDSET WOULD LAG AT 91% FOR A LONG TIME AND IT CAUSED THEM TO MISS BOLUSES. THE PATIENT STATED THAT THE LAG HAD BEEN HAPPENING SINCE IMPLANT. PER THE PTM (PERSONAL THERAPY MANAGER) THE PROGRAMMING WAS ¿BOLUS DURATION 4 MIN, LOCKOUT DURATION 2 HOURS, DOSE RESTRICTION 12 EVERY 24, MAX 12X DAY.¿ THE AGENT REVIEWED DATA AND WALKED THE PATIENT THROUGH DELETING THE DATA. THE PATIENT THEN STATED THAT THEY TURNED ON THE COMMUNICATOR AND WAITED FOR THE FLASHING LIGHT TO TURN SOLID BLUE AND THEN THEY CAN¿T CONNECT TO THE PUMP ¿ THE HANDSET SHOWS NOT FOUND, COMMUNICATOR. THE AGENT REVIEWED GENERAL USE OF BOTH EXTERNAL DEVICES, AND THE PATIENT WAS ABLE TO CONNECT TO THE PUMP MULTIPLE TIMES WHILE ON THE CALL. THE PATIENT STATED THAT THEY WERE NOT ABLE TO BOLUS OVER THE WEEKEND DUE TO THE HANDSET NOT FINDING THE COMMUNICATOR AND THEY WANTED TO HAVE DIRECTION OF WHAT TO DO IF THAT WERE TO HAPPEN AGAIN. THE PATIENT ALSO STATED THAT THEY WERE NOT ABLE TO BOLUS AT WALMART, TYP ICALLY NEAR FITTING ROOMS. THE AGENT REVIEWED EMI (ELECTROMAGNETIC INTERFERENCE) AND HAD THE PATIENT TOGGLEOFF MOBILE DATA AND INSTRUCTED THE PATIENT TO TURN OFF THE HANDSET. THE PATIENT THEN STATED THAT THE POWER BUTTON WAS NOT WORKING, AND THEY WERE NOT ABLE TO POWER OFF THE HANDSET. PER THE PATIENT, IT HAPPENED FREQUENTLY WHERE THE POWER BUTTON DID NOT FUNCTION. THE AGENT REQUESTED A REPLACEMENT HANDSET FROM THE REPAIR DEPARTMENT BECAUSE THE PATIENT WAS UNABLE TO TURN OFF THE HANDSET AND THE PATIENT REPORTED SERVICE CODES 156 AND 389. PER THE PATIENT, THE PUMP WAS DELIVERING FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534358 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000422608

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female "SEE H11...."