BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 21346101 · Received February 10, 2025

    Report

    Report Number
    3004209178-2025-02402
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    December 28, 2023
    Report Date
    February 10, 2025
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID A820, SERIAL# UNKNOWN, PRODUCT TYPE SOFTWARE PRODUCT ID TM90T0, SERIAL# (B)(6), PRODUCT TYPE ACCESSORY 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 REGARDING A PATIENT RECEIVING BUPIVACAINE AND DILAUDID VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE PATIENT SERVICES AGENT FROM THE HCIT (HEALTHCARE INFORMATION TECHNOLOGY) AGENT. THE REASON FOR THE CALL WAS THAT THE PATIENT STATED THAT THEY WERE HAVING ISSUES CONNECTING THE COMMUNICATOR TO THE HANDSET. THE PATIENT STATED THAT THE HANDSET KEPT GETTING STUCK AT 90% AND WOULDN'T DELIVER A BOLUS. THE PATIENT STATED THAT THEY HAD PROBLEMS CONNECTING SINCE THEY GOT THEIR PUMP IN DECEMBER. THE HCIT AGENT INFORMED THE PATIENT SERVICES AGENT THAT THEY HAD ALREADY DONE HANDSET TROUBLESHOOTING TO TRY AND RESOLVE THE ISSUE INCLUDING FORCE STOPPING, RESTARTING, AND TURNING BLUETOOTH ON AND OFF BUT THAT DID NOT RESOLVE ISSUE. THE PATIENT MENTIONED THEY HAD LOST "SO MANY BOLUSES AT NIGHT BECAUSE THEY CAN'T CONNECT AND ARE IN SO MUCH PAIN." A REPLACEMENT COMMUNICATOR WAS REQUESTED FROM THE REPAIR DEPARTMENT DUE TO THE POOR COMMUNICATION. ADDITIONAL INFORMATION WAS RECEIVED FROM HCIT (HEALTHCARE INFORMATION TECHNOLOGY) WHO REPORTED THAT A COMPANY REPRESENTATIVE HAD CALLED AND CONFERENCED ON THE PATIENT WHO WAS HAVING ISSUES PAIRING HER COMMUNICATOR TO HER HANDSET AND PUMP. THE COMPANY REPRESENTATIVE STATED THAT THE PATIENT COULDN¿T GET A BOLUS BECAUSE IT KEPT GETTING STUCK AT 90% WHEN PAIRING. THE COMPANY REPRESENTATIVE STATED THAT THEY CLOSED OUT OF EVERYTHING AND RESTARTING BOTH THE COMMUNICATOR AND THE HANDSET, AND IT WAS STILL GETTING STUCK AT 90%. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS/TROUBLESHOOTING PERFORMED WHEN WORKING WITH HCIT INCLUDED [FORCED STOPPED COMMUNICATION MANAGER; TURNED AIRPLANE MODE ON/OFF TWICE; TURNED LOCATION OFF & ON; CLOSED ALL OPEN APPS; HARD REBOOTED THE HANDSET. PATIENT STATED THAT IT SAYS, "RETRIEVING PUMP SETTINGS" AND THAT IT GOT STUCK AT THE 90% MARK AGAIN; WARM TRANSFERRED TO PATIENT-TO-PATIENT SERVICES.] THE INTERVENTIONS/ACTIONS TAKEN BY HCIT WERE NOTED TO BE [PATIENT STATED THAT IT SAYS, "RETRIEVING PUMP SETTINGS" AND THAT IT GOT STUCK AT THE 90% MARK AGAIN; WARM TRANSFERRED TO PATIENT-TO-PATIENT SERVICES.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684161 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00763000634100

    Patients

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