BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 19903538 · Received August 4, 2024

    Report

    Report Number
    3004209178-2024-16041
    Event Type
    Injury
    Date Received
    August 4, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 4, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING BACLOFEN VIA AN IMPLANTED PUMP. THE INDICATION USE WAS FOR NON-MALIGNANT PAIN. THE HEALTHCARE PROVIDER (HCP) REACHED OUT REQUESTING A COMPANY REPRESENTATIVE (REP) TO COME TO THE HOSPITAL TO INTERROGATE A PUMP. THE HCP STATED THAT THE PATIENT WAS UNRESPONSIVE. THEY WILL CHECK FOR MEDICATION TOXICITY OR WITHDRAWAL. THE TECHNICAL SERVICE TRANSFERRED CALLER TO THE NATIONAL ANSWERING SERVICE (NAS). (B)(6) 2024 MASRES1: PC TO RENATA SZUWALD AT 8476575649. SPOKE WITH RENATA SZUWALD WHO INDICATED THAT THEY WERE NOT SURE IF THERE WAS AN ISSUE WITH THE PUMP BUT WHEN THEY TURNED OFF THE PUMP, THE PATIENT BECAME RESPONSIVE. ACTION/INTERVENTION: DECREASED THE DOSAGE TO 75 PERCENT THEN TURNED OFF THE PUMP ON 2024 (B)(6) AFTER THAT. OUTCOME: THE PATIENT WAS DISPATCHED FROM THE HOSPITAL AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371709 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Life Threatening| H