BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25062347 · Received May 1, 2026

    Report

    Report Number
    3006630150-2026-02831
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 8, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7172520 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL, AFTER WHICH ONE SPINAL CORD STIMULATOR (SCS) LEAD APPEARED TO HAVE MIGRATED APPROXIMATELY HALF A VERTEBRAL BODY. LEAD MOVEMENT WAS CONFIRMED BY X-RAY IMAGING. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317727 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7172875 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention