BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24867478 · Received April 13, 2026

    Report

    Report Number
    3006630150-2026-02315
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    August 1, 2025
    Report Date
    May 18, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED DATE IS AUGUST PER GFE RESPONSE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1216 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 781081 MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 16 IPG KIT UNIQUE IDENTIFIER (UDI) : (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7160814 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH A SPINAL CORD STIMULATION (SCS) SYSTEM EXPERIENCED A MAJOR LEAD MIGRATION, WHICH RESULTED IN INADEQUATE STIMULATION. AS A CONSEQUENCE, A REVISION PROCEDURE WAS PERFORMED AND THE SYSTEM WAS REPLACED. FOLLOWING THE PROCEDURE, THE PATIENT WAS REPORTED TO BE DOING WELL AND RECEIVING ADEQUATE STIMULATION. THE FACILITY RETAINED THE EXPLANTED DEVICES AND INDICATED THEY WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107671 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7160813 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1