BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24062893 · Received January 13, 2026

    Report

    Report Number
    3006630150-2026-00316
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 20, 2025
    Report Date
    March 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SC-2218-50 DEVICES WITH SERIAL NUMBERS (B)(6) WERE NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. A REVIEW OF THE PRODUCT LABELING DID NOT REVEAL ANY ANOMALIES. THE LABELING NOTES THAT SYSTEM FAILURE MAY OCCUR AT ANY TIME DUE TO RANDOM COMPONENT OR BATTERY FAILURES. SUCH EVENTS INCLUDING DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS, AND LEAD INSULATION BREACHES CAN RESULT IN INEFFECTIVE PAIN CONTROL. ADDITIONALLY, UNDESIRABLE STIMULATION MAY DEVELOP OVER TIME DUE TO CELLULAR CHANGES IN TISSUE SURROUNDING THE ELECTRODES, ELECTRODE MIGRATION, LOOSE ELECTRICAL CONNECTIONS, OR LEAD FAILURE. THESE RISKS ARE INHERENT TO THE IMPLANTATION OF A PULSE GENERATOR AS PART OF A SPINAL CORD STIMULATION SYSTEM. BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS ASSIGNED THE INVESTIGATION CONCLUSION CODE: KNOWN INHERENT RISK OF DEVICE.BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.PRODUCT FAMILY: SCS-LINEAR LEADSUPN: M365SC2218500 MODEL: SC-2218-50SERIAL: 7161900BATCH: 7161900UDI: (01)08714729767725(17)270326(10)7161900(21)7161900

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7161900 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. THE PATIENT IS AWAITING HIS POSTOPERATIVE APPOINTMENT. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. THE PATIENT IS AWAITING HIS POSTOPERATIVE APPOINTMENT. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520367 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7166453 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention