BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25053307 · Received April 30, 2026

    Report

    Report Number
    3006630150-2026-02786
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50E SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7180761 MODEL/CATALOG DESCRIPTION: LINEAR ST TRIAL LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI #): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) TRIAL LEAD MIGRATION. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135173 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50E 7180749 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention