BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18163035 · Received November 17, 2023

    Report

    Report Number
    3006630150-2023-07145
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    August 25, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE WEEKS AFTER THE IMPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7128917. PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 220973.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN THE RIBS. X-RAY SHOWED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEADS WERE REPOSITIONED AND ONE OF THE LEADS WAS REPLACED. ALSO, THE IPG WAS MOVED TO THE OTHER SIDE FOR COMFORTABILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668101 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7128755 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention