BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18655824 · Received February 6, 2024

    Report

    Report Number
    3006630150-2024-00515
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    August 25, 2023
    Report Date
    March 4, 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 APPROXIMATELY ABOUT A WEEK AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7123608; PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 559519.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ITCHINESS, MILD PURULENCE AND PAIN AROUND THE INCISION SITE OF THE LEADS. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ITCHINESS, MILD PURULENCE AND PAIN AROUND THE INCISION SITE OF THE LEADS. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICES WERE DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440270 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7121313 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention