BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24834949 · Received April 9, 2026

    Report

    Report Number
    3006630150-2026-02206
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    October 23, 2025
    Report Date
    April 9, 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
    WA, 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: 7149636, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5153508, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5126065, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 33029882, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) : (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 24214473, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) : (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 26129440, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) : (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1232, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 764564, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 32 IPG KIT, UNIQUE IDENTIFIER (UDI) : (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THATIT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS MIGRATED AND EXPERIENCED INCREASE PAIN AFTER A NONDEVICE RELATED FALL. THE PATIENT UNDERWENT AN SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895891 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7149515 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention