BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25124956 · Received May 8, 2026

    Report

    Report Number
    3006630150-2026-02984
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7111557 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) LEAD MIGRATION WHICH WAS CONFIRMED THROUGH IMAGING. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310446 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7111501 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention