BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24035495 · Received January 12, 2026

    Report

    Report Number
    3006630150-2026-00267
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 17, 2025
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1416, SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 232842, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 16 IPG KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES COMPONENTS WERE NOT RETURNED, AS THEY WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES COMPONENTS WERE NOT RETURNED, AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259727 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7158897 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1