BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 24454069 · Received February 26, 2026

    Report

    Report Number
    3004209178-2026-03406
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 26, 2024
    Report Date
    February 26, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634100
    PMA / PMN Number
    P860004
    Removal / Correction Number
    2182207-01-24-2025-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID A820; SERIAL# UNKNOWN. 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 CONSUMER AND A HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY HAD BEEN HAVING ISSUES WITH THEIR PTM (PERSONAL THERAPY MANAGER) FOR THE LAST MONTH OR TWO. THE PATIENT STATED THAT THE PTM WOULD READ "FROM 0-100 PRETTY QUICK," BUT AS TIME WENT BY AFTER THEIR REFILL, IT "SLOWS DOWN DRAMATICALLY TO 71 AND THEN GOES TO 91 AND SITS THERE." THE PATIENT ALSO STATED THAT THEY WERE HAVING TO ¿MOVE THE COMMUNICATOR ALL OVER THE PLACE TO GET IT TO OPERATE AND HAVE TOMOVE IT 3-4 TIMES TO GET ONE BOLUS BECAUSE IT SAYS, ¿NO PUMP DETECTED.¿" THE AGENT REVIEWED GENERAL USE AND CONSIDERATIONS FOR CONNECTING TO THE PUMP. THE PATIENT STATED THAT THEY TURNED THE HANDSET OFF AND BACK ON EVERY NIGHT. DURING THE CALL, THE PATIENT WAS ABLE TO CONNECT TO THEIR PUMP WITHOUT ANY ISSUES. THE AGENT HAD THE PATIENT TOGGLE AIRPLANE MODE ON AND OFF, AND THE PATIENT WAS GOING TO CALL BACK IF THE ISSUES PERSISTED. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 4, 2024, FROM A HEALTHCARE PROVIDER WHO REPORTED THAT THE CAUSE OF THE CONNECTIVITY IS SUES WITH THE EXTERNAL DEVICES WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517476 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00763000634100

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male