BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23501336 · Received November 7, 2025

    Report

    Report Number
    3006630150-2025-10142
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    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: M365SC221850E0 MODEL: SC-2218-50E SERIAL: (B)(6) BATCH: 7161553 UDI: ((B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEW PAIN IN THE UPPER RIGHT EXTREMITY WHEN THE THERAPY WAS TURNED OFF. PER THE PHYSICIAN, THE PATIENT HAD NERVE ROOT IRRITATION FROM THE PROCEDURE. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE AND REPORTED RELIEF OF THE NEW PAIN. THE PULLED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181116 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50E 7166859 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention