BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17453410 · Received August 3, 2023

    Report

    Report Number
    3006630150-2023-04540
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7041131.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD MIGRATED AND WAS CAUSING DISCOMFORT AT THE LEAD AREA AND THE LEGS. LEAD MIGRATION WAS CONFIRMED THROUGH A COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284742 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7073907 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention