BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20077607 · Received August 27, 2024

    Report

    Report Number
    3006630150-2024-05645
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    February 1, 2024
    Report Date
    August 27, 2024
    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 (B)(6) 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7091283.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH LEADS WERE MOVED DOWN TO COVER PAINFUL AREAS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS REMAIN IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478457 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7091481 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention