BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25272636 · Received May 25, 2026

    Report

    Report Number
    3006630150-2026-03460
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7170039. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318. BATCH/LOT NUMBER: 37085914. MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATION (SCS) LEAD MIGRATION AS CONFIRMED WITH X-RAY. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538164 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7170056 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1