BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23625009 · Received November 21, 2025

    Report

    Report Number
    3006630150-2025-10702
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    June 1, 2025
    Report Date
    November 21, 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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED WITHIN THE LAST FEW WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7163137, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE OF OPTIMIZING THE PROGRAM. IMAGING CONFIRMS RIGHT LEAD MIGRATION. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) PROCEDURE. PATIENT DOING WELL POSTOPERATIVELY. EXPLANTED PRODUCTS WILL NOT BE RETURNED DUE TO FACILITY PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117921 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7164219 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention