BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24382266 · Received February 18, 2026

    Report

    Report Number
    3006630150-2026-00977
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    December 31, 2025
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7075336, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7080881, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270846 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7080367 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention