BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN? MRI

    MDR report key: 23461864 · Received November 4, 2025

    Report

    Report Number
    3006630150-2025-09967
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951131
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416500. MODEL: SC-8416-50. SERIAL: (B)(6). BATCH: 7072449. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED, AND TWO NEW LEADS WERE ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558047 ARTISAN? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8416-70 21269746 08714729951131

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention