BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 21185776 · Received January 17, 2025

    Report

    Report Number
    3006630150-2025-00085
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7152946.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT BRADYCARDIC DURING THE IMPLANT PROCEDURE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS STABILIZED. IT WAS NOTED THAT THE PHYSICIAN BELIEVED THAT THE PATIENT HAD VASOVAGAL REACTION CAUSING THE HEART RATE OF THE PATIENT TO DROP. THE PHYSICIAN DID NOT BELIEVE THIS WAS RELATED TO THE SPINAL CORD STIMULATOR (SCS) EQUIPMENT. THE DEVICE WAS KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140716 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7152939 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention