BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17103782 · Received June 12, 2023

    Report

    Report Number
    3006630150-2023-03309
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(4). BATCH: 7091308.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ANESTHESIA RELATED COMPLICATIONS DURING THE IMPLANT PROCEDURE. IT WAS NOTED THAT UPON PLACEMENT OF THE LEADS, THE PATIENTS OXYGEN SATURATION DROPPED AND THE CASE WAS ABORTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274589 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7091348 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention