BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22847035 · Received August 20, 2025

    Report

    Report Number
    3006630150-2025-06670
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 20, 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
    WA, 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: 7142939. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE WHEN THE TRIAL PERIOD BEGAN. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. THE PATIENT STILL REPORTED DISCOMFORT AT THE SITE HOWEVER IS DOING WELL UPON FOLLOW-UP. THE REMOVED LEADS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408196 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50E 7142929 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention