BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 24725880 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01901
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    June 14, 2022
    Report Date
    March 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ON THE IMPLANT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8416-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7072338, MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO INADEQUATE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY AND 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
    791247 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 374155 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention