BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24214451 · Received January 29, 2026

    Report

    Report Number
    3006630150-2026-00600
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    August 28, 2025
    Report Date
    January 29, 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
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7112543, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES AND GETS BUZZING IN HER LEGS. THE BUZZING IS MORE SIGNIFICANT IN THE RIGHT LEG AND WAS FOUND TO HAVE INFERIOR LEAD MIGRATION. THE PATIENT UNDERWENT AN SCS LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. PATIENTS DEVICE IS WORKING CORRECTLY AND NOTHING WILL RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277559 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7113654 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention