BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16315771 · Received February 7, 2023

    Report

    Report Number
    3006630150-2023-00465
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    December 1, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7111058.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAD MIGRATION WHICH WAS CONFIRMED THROUGH IMAGING. THE SPINAL CORD STIMULATION (SCS) DEVICE WAS REPROGRAMMED, COVERAGE WAS OBTAINED, AND THE PATIENT WAS SATISFIED WITH THE RESULTS. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229338 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7111489 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention