BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22543505 · Received July 18, 2025

    Report

    Report Number
    3006630150-2025-05613
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    March 12, 2025
    Report Date
    July 17, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7142575. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI: UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 786251. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT NO LONGER HAD GOOD COVERAGE. X-RAY WAS TAKEN WHICH SHOWED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396429 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7135956 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention