BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18160684 · Received November 17, 2023

    Report

    Report Number
    3006630150-2023-07133
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY FEW DAYS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6). BATCH: 7132692. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160, MODEL: SC-1416, SERIAL, (B)(6). BATCH: 213311.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEAD INCISION LOOKED LIKE IT WAS NOT HEALING PROPERLY. SYMPTOMS OF SWEATS AND FEVER WERE NOTED. THE PHYSICIAN BELIEVED THE INFECTION IS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN SPINAL CORD STIMULATION (SCS) WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917309 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7123440 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention