BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24422577 · Received February 23, 2026

    Report

    Report Number
    3006630150-2026-01062
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    December 5, 2025
    Report Date
    April 17, 2026
    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

    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: 7163296, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD MAY HAVE MOVED DUE TO NON-DEVICE RELATED FALL. UNDESIRED NON-TARGET STIMULATION AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WAS ALSO NOTED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD MAY HAVE MOVED DUE TO NON-DEVICE RELATED FALL. UNDESIRED NON-TARGET STIMULATION AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WAS ALSO NOTED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372151 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7166603 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1