BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24406991 · Received February 20, 2026

    Report

    Report Number
    3006630150-2026-01039
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL:SC-2218-70. SERIAL: (B)(6). BATCH: 7092323. UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO SPINAL CORD STIMULATION (SCS) LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POST OPERATIVELY. NOTHING ADDED OR REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO SPINAL CORD STIMULATION (SCS) LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. NO OTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197138 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7092323

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention