BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 20044360 · Received August 22, 2024

    Report

    Report Number
    3004209178-2024-17207
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00763000634100
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 HEALTH CARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED THAT THE PATIENT CAME IN FOR REFILL TWO DAYS AGO AND THE PUMP CONTINUED TO ALARM AFTER THE PATIENT WENT HOME. THE HCP STATED THE PATIENT WAS BACK NOW AND HE REINTERROGATED THE PUMP, CHECKED LOGS, AND NO NEW ALERTS WERE POPULATING. TECHNICAL SERVICES CONFIRMED THE HCP HAD ALREADY CLICKED INTO A WORKFLOW AND UPDATED THE PUMP. TECHNICAL SERVICES ALSO CONFIRMED THE PATIENT HAD REACHED LOW RESERVOIR (LRA) PRIOR TO THE REFILL AND CONFIRMED THE HCP HAD UPDATED SOFTWARE ON TABLET AND ITERATED THAT THIS WAS A KNOWN ISSUE WHERE LRA WAS NOT SILENCED AFTER THE UPDATE. TECHNICAL SERVICES HAD THE HCP REINTERROGATE THE PATIENT'S PUMP AND CONFIRM NO ACTIVE ALARM BANNER WAS PRESENT AND PUMP ALARM HAD BEEN SILENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256753 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00763000634100

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male