BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20575993 · Received October 31, 2024

    Report

    Report Number
    3006630150-2024-07437
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 31, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7146322. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43160. MODEL: SC-4316. BATCH: 33872609.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SHARP LOCALIZED PAIN AT LEAD ANCHOR SITE THAT RADIATE INTO THE CHEST WALL. IT WAS ALSO NOTED THAT WITH CERTAIN POSITIONS, THE PATIENT WOULD EXPERIENCE JOLTING SHARP PAIN INTO THE RIB CAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR AND LEADS WERE REPLACED AND RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011097 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7146321 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention