BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 19851658 · Received July 29, 2024

    Report

    Report Number
    3004209178-2024-15635
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 31, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. 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

    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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING BUPIVACAINE (UNK MG/ML AT UNK MG/DAY), UNKNOWN MORPHINE DRUG (UNK MG/ML AT UNK MG/DAY), AND DILAUDID (HYDROMORPHONE) (UNK MG/ML AT UNK MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS A PUMP MEMORY ERROR (PME) WHEN INTERROGATING THE PUMP WITH SERVICE CODE 243. THE HEALTHCARE PROVIDER (HCP) STATED THAT THE PATIENT COMPLAINED OF A "FLARE UP OF PAIN" OVER THE PAST MONTH AND A HALF. THE AGENT HAD THE HCP READ PUMP LOGS WHICH SHOWED NO ALARMS OR ALERTS; THE AGENT REVIEWED THAT PME OCCURRED WHEN PUMP WAS INTERROGATED AND REVIEWED THAT PUMP WOULD NEED TO HAVE INFUSION SETTINGS ENTERED AND PUMP UPDATED AGAIN. ASSISTED CALLER IN ENTERING FLEX PROGRAMMING SETTINGS. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. THE TECHNICAL SERVICE (TS) STATED THAT THERE WERE MULTIPLE CALLS ASSOCIATED WITH THIS RECORD DUE TO CALL CONNECTION BEING LOST DURING THE CONVERSATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE "FLARE UP OF PAIN" DID NOT APPEAR TO BE A DEVICE ISSUE. THE REP STATED THAT CHRONIC PAIN WAS DYNAMIC AND THE PATIENT POSSIBLY EXPERIENCED BREAKTHROUGH PAIN. THE CAUSE OF THE PUMP MEMORY ERROR WAS NOT DETERMINED. THE REP WAS NOT SURE WHAT ACTIONS/INTERVENTIONS WERE TAKEN AND STATED THAT IT WAS UP TO THE DOCTOR AND WOULD BE DETERMINED. THE REP WAS NOT SURE IF THE ISSUE HAD RESOLVED AS THE PATIENT WAS TO FOLLOW-UP WITH THE DOCTOR, TO BE DETERMINED (TBD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375026 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female