BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR? ST

    MDR report key: 24477139 · Received February 27, 2026

    Report

    Report Number
    3006630150-2026-01177
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7123240. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEADS WERE FRACTURED WHICH WAS CONFIRMED WITH IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536045 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7123016 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male