BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23908587 · Received December 29, 2025

    Report

    Report Number
    3006630150-2025-11731
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 29, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7172423, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD MIGRATED. LEAD MIGRATION WAS CONFIRMED THRU X-RAY IMAGING. THE PATIENT UNDERWENT A SCS LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES REMAINED IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2848103 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7171227 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention