BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25088184 · Received May 5, 2026

    Report

    Report Number
    3006630150-2026-02908
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 5, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7070034 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UD I)# : (B)(4). NUMBER/CATALOG NUMBER: SC-1232. SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 529382. MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 32 IPG KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MID BACK PAIN OR TIGHTNESS WHEN STIMULATION THERAPY WAS TURNED ON, WHICH WAS DESCRIBED AS A MUSCLE SPASM LIKE SENSATION IN THE MID BACK AREA. A LEAD CHECK WAS PERFORMED, AND LEAD MIGRATION WAS IDENTIFIED. THE PATIENT SUBSEQUENTLY UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICES WERE DISCARDED PER HOSPITAL POLICY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284975 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7100356 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention