BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24835512 · Received April 9, 2026

    Report

    Report Number
    3006630150-2026-02212
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 7072095 UDI# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEADS WERE REVISED AND PULLED DOWN TO PROVIDE BETTER COVERAGE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897296 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7072101 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention