BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED III

    MDR report key: 21739133 · Received April 1, 2025

    Report

    Report Number
    3004209178-2025-05608
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 21, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000597023
    PMA / PMN Number
    P860004
    Removal / Correction Number
    2182207-01-24-2025-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID A820 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE SOFTWARE SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A820, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: 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

    THE PATIENT CALLED BACK REQUESTING HELP WITH CLEARING DATA. THE AGENT WALKED THE PATIENT THROUGH IT AND THE PATIENT STATED IT WAS RUNNING MUCH FASTER NOW.

    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 SPINAL PAIN INDICATIONS. ON MARCH 31ST THE PATIENT REPORTED FOR THE PAST 3 WEEKS THEY HAVE BEEN SEEING ¿PLEASE WAIT¿ AND ¿CLOSE APPS¿ WHEN TRYING TO CONNECT TO THEIR PUMP. THIS MORNING THE HANDSET WOULDN'T READ THE BLUETOOTH, AND THEY HAD TO SHUT IT DOWN TWICE. THE PATIENT CONFIRMED THEY HAVE NOT TRIED CLEARING THE DATA TO SEE IF THAT RESOLVES THE ISSUE. THE PATIENT WAS ASSISTED WITH CLEARING DATA OF THE HANDSET. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE AND THE PATIENT WOULD CALL BACK IF ISSUE PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040528 SYNCHROMED III PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8667-20 00763000597023

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female "SEE H11....".