BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR

    MDR report key: 24336903 · Received February 13, 2026

    Report

    Report Number
    3006630150-2026-00879
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 21, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: SC-2108-50M. MODEL: SC-2108-50M. SERIAL: (B)(6) BATCH: 7860. UDI: UNK. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 230500. UDI: (B)(4). PRODUCT FAMILY: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 229714. UDI: (B)(4). D4: THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35802 LINEAR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2108-50M 6072

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention