BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24314170 · Received February 11, 2026

    Report

    Report Number
    3006630150-2026-00829
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 19, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    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: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7168349. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416 SERIAL: (B)(6). BATCH: 240664. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SUPPOSED LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION AFTER A FALL, IT WAS FOUND OUT THAT BOTH INCISION SITES WERE HIGHLY INFECTED. IT WAS HOT TO TOUCH, WAS LEAKING, AND OPENED. THE PHYSICIAN BELIEVED THAT IT WAS NOT DEVICE OR PROCEDURE RELATED. THE PHYSICIAN OPTED TO EXPLANT THE SYSTEM. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281671 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7172024 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention