BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20286336 · Received September 23, 2024

    Report

    Report Number
    3006630150-2024-06371
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: M365SC221850E0. MODEL: SC-2218-50E. SERIAL: (B)(6). LOT: 7122876.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL DAYS AFTER A SPINAL CORD STIMULATION TRIAL LEAD IMPLANT PROCEDURE, THE PATIENT FELT NAUSEOUS AND LETHARGIC. THE PATIENT WAS INSTRUCTED TO TURN THE STIMULATION OFF. THE PATIENT WAS LATER ADMITTED TO THE HOSPITAL AND TREATED FOR A BRAIN ANEURYSM. THE PHYSICIAN ASSESSED THE EVENT WAS NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360979 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 7137804 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| O| H