BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23027603 · Received September 11, 2025

    Report

    Report Number
    3006630150-2025-07485
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    July 23, 2023
    Report Date
    September 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7122208, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 564466, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING WAS TAKEN AND SPINAL CORD STIMULATION (SCS) LEAD MIGRATION WAS CONFIRMED. THE PATIENT UNDERWENT A PROCEDURE AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675940 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7122488 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention