BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17271633 · Received July 6, 2023

    Report

    Report Number
    3006630150-2023-03948
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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)(6), BATCH: 7090993.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPERIENCED LOSS OF COVERAGE ON THE RIGHT SIDE DUE TO LEAD MIGRATION. THE LEAD WAS REVISED AND REMAINS IMPLANTED IN THE PATIENT. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039269 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7090767 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention