BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23262812 · Received October 9, 2025

    Report

    Report Number
    3006630150-2025-08646
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    August 18, 2025
    Report Date
    November 14, 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
    AZ, 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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7163039, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 36390238, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE WHICH WAS CONFIRMED WITH IMAGING. LOSS OF COVERAGE FROM THE DEVICE WAS ALSO NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE WHICH WAS CONFIRMED WITH IMAGING. LOSS OF COVERAGE FROM THE DEVICE WAS ALSO NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303598 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7163122 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention