BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 21209678 · Received January 22, 2025

    Report

    Report Number
    3006630150-2025-00135
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 29, 2024
    Report Date
    January 22, 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
    CO, 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: 7143355.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED AS CONFIRMED VIA IMAGING CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683240 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7142873 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention