BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24323179 · Received February 12, 2026

    Report

    Report Number
    3006630150-2026-00852
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    July 30, 2024
    Report Date
    April 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER A YEAR AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7090914, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 510290, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180, MODEL: SC-4318 , BATCH: 26612865, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TINGLING SENSATION THAT FELT LIKE SHOCKS WHEN THE DEVICE WAS TURNED UP AND ON. THE LEAD HAD HIGH IMPEDANCES. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383879 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7090959 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention