BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22565585 · Received July 22, 2025

    Report

    Report Number
    3006630150-2025-05737
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 15, 2024
    Report Date
    September 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H11. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7072297 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS RIGHT SPINAL CORD STIMULATION (SCS) LEAD MIGRATED AS REVEALED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS RIGHT SPINAL CORD STIMULATION (SCS) LEAD MIGRATED AS REVEALED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755861 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7071860

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention