BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23851295 · Received December 19, 2025

    Report

    Report Number
    3006630150-2025-11561
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 1, 2024
    Report Date
    December 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER A YEAR PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 220049 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) LEADS WERE MOVED DOWN FROM ITS RECENT POSITION. THE PATIENT WAS DOING WELL POSTOPERATIVELY WITH APPROPRIATE COVERAGE OF PAIN AREAS. THE DEVICES REMAIN IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257200 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 220264 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention