BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 21454131 · Received February 24, 2025

    Report

    Report Number
    3006630150-2025-01003
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7081684.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO HIGH IMPEDANCE ON LEADS, PATIENT IS RECOVERING WELL, COVERAGE OF ALL PAIN AREAS. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403463 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7081343 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention