BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24388578 · Received February 19, 2026

    Report

    Report Number
    3006630150-2026-00987
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7112320, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT, PAIN AND WEAKNESS AFTER PHYSICIAN ATTEMPTED TO ENTER THE TOUHEY NEEDLE INTO THE EPIDURAL SPACE. UPON ENTRANCE, CLEAR LIQUID BELIEVED TO BE CSF SURFACED THROUGH NEEDLE. PHYSICIAN COMPLETED PROCEDURE AND ATTEMPTED A BLOOD PATCH, UNSUCCESSFULLY AS THEY WERE UNABLE TO DRAW BLOOD FROM PATIENT. PATIENT WAS ADVISED TO LAY FLAT AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453174 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7112357 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention