BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 20464548 · Received October 16, 2024

    Report

    Report Number
    3006630150-2024-07005
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 7150885.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THAT WAS ABORTED DUE TO CEREBROSPINAL FLUID LEAKAGE. IT WAS NOTED THAT PATIENT WAS PLACED UNDER ANESTHESIA. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562795 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7152539 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention