BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24735333 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01929
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    December 31, 2025
    Report Date
    May 21, 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
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 374158, MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7082880, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A FALL UNRELATED TO DEVICE STIMULATION THAT RESULTED IN INADEQUATE STIMULATION AND LEADS MIGRATION, AND AS A RESULT, THE IMPLANTABLE SYSTEM WAS REPLACED. POSTOPERATIVELY, THE PATIENT IS DOING WELL. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267402 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7080622 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1