BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23044492 · Received September 12, 2025

    Report

    Report Number
    3006630150-2025-07575
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 7160439, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN EARLY SPINAL CORD STIMULATION (SCS) LEAD PULL DUE TO SEVERE COMPLICATIONS. THE PATIENT BEGAN TO EXPERIENCE WEAKNESS AND PAIN ON THE LEFT SIDE, WHICH WAS OPPOSITE TO THE LEAD PLACEMENT. THE PATIENT ALSO REPORTED SEVERE NAUSEA AND VOMITING WHILE THE STIMULATOR WAS ACTIVE, ALONG WITH DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700208 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50E 7160329

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention