BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 21402562 · Received February 18, 2025

    Report

    Report Number
    3004209178-2025-03024
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    November 5, 2024
    Report Date
    February 18, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634094
    PMA / PMN Number
    P860004
    Removal / Correction Number
    2182207-01-24-2025-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID A820, PRODUCT TYPE SOFTWARE 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 HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER REPORTED TO THE COMPANY REPRESENTATIVE THAT THEY HAD A PATIENT WHOSE PTM (PERSONAL THERAPY MANAGER) TAKES ABOUT 9 MIN TO CONNECT. THE COMPANY REPRESENTATIVE WOULD LIKE TO SEE IF THERE'S ANYTHING THAT NEEDS TO BE UPDATED OR ADJUSTED IN SETTINGS. THE HEALTHCARE IT REPRESENTATIVE INFORMED THE COMPANY REPRESENTATIVE THAT THEY HAD BEEN SEEING A HANDFUL OF CALLS REGARDING TELEMETRY DELAYS ON PTM¿S, AND ENGINEERS WERE LOOKING INTO THE ISSUE. THE COMPANY REPRESENTATIVE WAS INFORMED TO HAVE THE PATIENT CONTACT PATIENT SERVICES TO SEE IF THEY HAVE OTHER INSIGHT, OTHERWISE REPLACE HANDSET. THE COMPANY REPRESENTATIVE WOULD PROVIDE INFO TO THE HEALTHCARE PROVIDER AND PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THE SAME DAY FROM THE PATIENT VIA THE COMPANY REPRESENTATIVE WHO REPORTED THE PTM (PERSONAL THERAPY MANAGER) GETS STUCK AT 90% FOR A LONG TIME WHEN THE PATIENT REQUESTS A BOLUS. THE COMPANY REPRESENTATIVE CONFERENCED ON THE PATIENT¿S HUSBAND, TRIED CLEARING PDS DATA TO SEE IF THAT WOULD RESOLVE THE ISSUE BEFORE REPLACING THE HANDSET. THE PATIENT COMMUNICATED WITH TH E PUMP AND SAID IT WENT THROUGH RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540572 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000634094

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female