BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24716653 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01872
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 15, 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
    UT, 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: 7170360, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 37398189, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE IN WHICH A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WERE NOT RETURNED IN ACCORDANCE WITH FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90608 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7170063 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1