BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24956131 · Received April 22, 2026

    Report

    Report Number
    3006630150-2026-02542
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 22, 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
    NC, 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: 7170529. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4316. BATCH/LOT NUMBER: 38032591. MODEL/CATALOG DESCRIPTION: CLIK ANCHOR. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD MIGRATED WHICH CAUSED THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION. X-RAY IMAGING WAS PERFORMED TO CONFIRM THE DEVICE MIGRATION. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY. THERE WAS NO DEVICE MALFUNCTION THAT WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446490 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7175255 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1