BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19106012 · Received April 15, 2024

    Report

    Report Number
    3006630150-2024-02367
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 21, 2024
    Report Date
    April 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7133954/7133257.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE MIDLINE INCISION DUE TO LEAD HAD MIGRATED AS CONFIRM WITH FLUOROSCOPE IMAGING. THE PHYSICIAN NOTICED SOME MILD DISTENTION ALL DUE TO EXTREME SCOLIOSIS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN SUTURE SLEEVES WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469444 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7133257 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention