BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24543167 · Received March 9, 2026

    Report

    Report Number
    3006630150-2026-01370
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    July 9, 2025
    Report Date
    May 28, 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: 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-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7090374. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM . UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318. BATCH/LOT NUMBER: 27975156. 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 AN INADEQUATE STIMULATION AND THE LEADS HAD MIGRATED. THE PATIENT EXPERIENCED AN UNDESIRED SENSATION IN AREAS THAT SHE WAS NOT IMPLANTED TO STIMULATE. PATIENT HAD BUZZING, TINGLING, AND NUMBNESS IN HER SIDES AND ABDOMEN, AND HAVE BEGUN FEELING EXCESSIVE LEVELS OF HEAVINESS AND FATIGUE IN HER BODY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND DURING THE PROCEDURE, IT WAS FOUND OUT THAT THE CLIK ANCHOR WAS NOT SUTURED COMPLETELY TO THE FASCIA AND THIS MAY HAVE BEEN THE REASON FOR MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336003 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7089712 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1