BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15393672 · Received September 9, 2022

    Report

    Report Number
    3006630150-2022-04654
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 9, 2022
    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

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(4). BATCH: 7081730.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A MIGRAINE A FEW HOURS AFTER THE DEVICE WAS TURNED ON. IT WAS ALSO NOTED THAT PATIENTS RIGHT HAND WAS SWELLING AND HURTING AND THE RIGHT LEG WERE SHAKING, HARD TO LIFT, WEAK AND UNBALANCED. THE PATIENT TURNED THE DEVICE OFF AND STARTED TO FEEL BETTER. AN X-RAY WAS TAKEN AND REVEALED THAT THE LEFT LEAD HAD MIGRATED DOWN. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806571 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7080825 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention