BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED III

    MDR report key: 24481817 · Received March 2, 2026

    Report

    Report Number
    3004209178-2026-03702
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Report Date
    March 2, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000597030
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID TM90T0 LOT# SERIAL # (B)(6); IMPLANTED: EXPLANTED: PRODUCT TYPE ACCESSORY SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: TM90T0, SERIAL/LOT #: (B)(6); , UBD: 19-AUG-2025, UDI#: (B)(4). H3: ANALYSIS OF THE COMMUNICATOR FOUND ¿MICRO USB CHARGE PORT GOT DAMAGE¿ 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 CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEIR COMMUNICATOR WAS ¿DEAD¿. THE PATIENT STATED IT WOULD KEEP A CHARGE BUT ONCE THEY UNPLUG IT, IT WOULD NOT STAY LIT UP AND IT IS JUST DEAD. THE COMMUNICATOR WOULD CHARGE TO GREEN AND THEN AFTER 1-2X USE THE COMMUNICATOR WAS FULLY DEPLETED AND THE BATTERY INDICATOR LIGHT WAS AMBER. THE AGENT HAD THE PATIENT TOGGLE OFF AIRPLANE MODE. WHILE ON THE CALL THE PATIENT TRIED TO CONNECT AFTER TOGGLING OFF AIRPLANE MODE AND THE HANDSET SAID NOT FOUND COMMUNICATOR. THE PATIENT STATED THE COMMUNICATOR TURNED ITSELF OFF. THE AGENT HAD THE PATIENT PLUG THE COMMUNICATOR INTO THE AC POWER CORD AND THE PATIENT STATED THE BATTERY INDICATOR LIGHT WAS AMBER/RED/ORANGE. A REQUEST WAS SENT FOR A REPLACEMENT COMMUNICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549421 SYNCHROMED III PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8667-40 00763000597030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female "SEE H11...."