BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22866624 · Received August 21, 2025

    Report

    Report Number
    3006630150-2025-06719
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 21, 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
    OH, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7161731. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418999 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7160568 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention