BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22922570 · Received August 29, 2025

    Report

    Report Number
    3006630150-2025-07009
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    October 21, 2024
    Report Date
    January 12, 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
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7111508. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 547083. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REVISION BUT WAS CANCELED DUE TO STAPHYLOCOCCUS AUREUS INFECTION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT REPLACEMENT PROCEDURE AND IS DOING WELL POSTOPERATIVELY. THE PATIENT HAS FULL PARESTHESIA COVERAGE OF HIS PAIN AREAS. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURN AS IT WAS DISPOSED BY THE CENTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT WAS SCHEDULED FOR REVISION BUT WAS CANCELED DUE TO STAPHYLOCOCCUS AUREUS INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222570 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7111375 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention