BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-6

    MDR report key: 23543242 · Received November 13, 2025

    Report

    Report Number
    3006630150-2025-10354
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    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

    D2B: LGW - 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: 7074875 UDI:(B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6) BATCH: 7072677/7072413 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120185 LINEAR? 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7073782 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention