BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 19949513 · Received August 9, 2024

    Report

    Report Number
    3004209178-2024-16401
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 9, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634094
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING INTRATHECAL MORPHINE (UNKNOWN) AND PRIALT (ZICONOTIDE) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN INDICATIONS. THE COMPANY REP REPORTED THAT THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) YESTERDAY AND TODAY THEY WERE NOT SEEING A MOTOR STALL RECOVERY IN LOGS. NO MENTION OF PATIENT SYMPTOMS. TECHNICAL SERVICE AGENT DISCUSSED WAITING 20 MIN AND REINTERROGATING/RECHECKING FOR MOTOR STALL RECOVERY AND DISCUSSED TELEMETRY MODE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE (REP) AND CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP) REPORTING THAT THE MOTOR STALL CLEARED AFTER 20-30 MIN WAIT. THEY STATED, "ALL CLEARED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174644 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00763000634094

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male