BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 23375883 · Received October 23, 2025

    Report

    Report Number
    3006630150-2025-09494
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 22, 2024
    Report Date
    October 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN FALL OF 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6). BATCH: 7081311. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN NON-TARGET AREAS. THE PATIENT UNDERWENT A NON-DEVICE RELATED PROCEDURE AND HAS NOTICED THAT THEIR LEAD MOVED FOLLOWING THE PROCEDURE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243403 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 375255 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention