BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23764006 · Received December 9, 2025

    Report

    Report Number
    3006630150-2025-11306
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 3, 2025
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SIX WEEKS AFTER IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 794880, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7101983, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7103043, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7109714, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEFT OCCIPITAL INCISION SITE, PRESENTING WITH REDNESS, SWELLING, AND PAIN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HOSPITALIZED. HIGH IMPEDANCE ON THE LEAD WAS ALSO NOTED. ALL DEVICE COMPONENTS WERE EXPLANTED AND DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106829 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7104025 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H