BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25173534 · Received May 14, 2026

    Report

    Report Number
    3006630150-2026-03139
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 21, 2026
    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
    TX, 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: 14500983. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1110-02. SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 212428. MODEL/CATALOG DESCRIPTION: PRECISION IPG KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4316. BATCH/LOT NUMBER: 14312621. MODEL/CATALOG DESCRIPTION: CLIK ANCHOR. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED IMAGING. PATIENT ALSO WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT LEAD EXPLANT PROCEDURE. PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISPOSED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139821 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 14500984 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1