BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22078594 · Received May 23, 2025

    Report

    Report Number
    3006630150-2025-03594
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 23, 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
    IL, 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 SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7133643. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE. UPON REMOVING THE OLD LEADS THE PHYSICIAN ATTEMPTED TO PLACE NEW LEADS, HOWEVER THERE WERE LOTS OF SCAR TISSUE PRESENT THE LEADS WERE ANTERIOR AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN DECIDED TO ABORT THE CASE. NOTHING IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320942 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7133521 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention