BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22374879 · Received July 1, 2025

    Report

    Report Number
    3006630150-2025-05027
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7151185. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. TINGLING SENSATION IN LEFT BIG TOE AND RIGHT FOOT WITH INCREASED INTENSITY WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206447 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7151222 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention