BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16878584 · Received May 5, 2023

    Report

    Report Number
    3006630150-2023-02525
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729820741
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: M365SC221870E0, MODEL: SC-2218-70E, SERIAL: (B)(6), BATCH: 7081073.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT BECAME SICK TO HER STOMACH A DAY AFTER THE TRIAL IMPLANT PROCEDURE AND IN THE MORNING WHEN SHE WOKE UP, SHE WAS UNABLE TO SPEAK NORMALLY. THE PATIENT EXPERIENCED A SEIZURE AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE PHYSICIAN DOES NOT BELIEVE THAT THE SEIZURE WAS DEVICE RELATED. THE TRIAL LEADS WERE EXPLANTED TO PERFORM IMAGING AND BLOODWORK. THE PATIENT WAS DOING FINE POST-OPERATIVELY AND HAS NOT EXPERIENCED ANY FURTHER SEIZURES. THE EXPLANTED TRIAL LEADS WERE NOT RETURNED PER MEDICAL FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195087 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70E 7081063 08714729820741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H