BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24056086 · Received January 13, 2026

    Report

    Report Number
    3006630150-2026-00305
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    March 12, 2025
    Report Date
    February 27, 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
    TX, 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: 7103649, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEADS WERE CUT DURING A BACK SURGERY PROCEDURE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD ADDITION PROCEDURE AND PATIENT WAS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEADS WERE CUT DURING A BACK SURGERY PROCEDURE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD ADDITION PROCEDURE AND PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117477 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7103395 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention