BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 21032302 · Received December 29, 2024

    Report

    Report Number
    3006630150-2024-09126
    Event Type
    Injury
    Date Received
    December 29, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7150752.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT X-RAY WAS TAKEN WHICH SHOWED THAT THE LEFT LEAD MIGRATED AND IN TURN THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS PULLED DOWN TO GET BETTER COVERAGE OF THE PAIN AREAS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428163 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7148330 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention