BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24916899 · Received April 17, 2026

    Report

    Report Number
    3006630150-2026-02436
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    November 6, 2025
    Report Date
    May 14, 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
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080095 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS THAT THE SPINAL CORD STIMULATOR (SCS) LEAD OF THE PATIENT HAD MIGRATED. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS THAT THE SPINAL CORD STIMULATOR (SCS) LEAD OF THE PATIENT HAD MIGRATED. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548091 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7079479 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1