BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 23639323 · Received November 24, 2025

    Report

    Report Number
    3006630150-2025-10768
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7083582 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED EDEMA AT THE DISTAL TIP OF ONE OF THE LEADS, ACCOMPANIED BY TENDERNESS, SWELLING LOCATED AT THE LEFT EYEBROW OUTER CORNER. DRAINAGE WAS SUCCESSFULLY PERFORMED, AND THE PATIENT WAS DOING WELL. IT IS SUSPECTED THAT THE CAUSE OF LEAD EDEMA WAS FRICTION/IRRITATION FROM THE TIP OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313674 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7083662 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention