BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17858486 · Received October 3, 2023

    Report

    Report Number
    3006630150-2023-05985
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    June 12, 2023
    Report Date
    January 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5043205. PRODUCT FAMILY: SCS-IPG-R-MRI , UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 528482.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A HARD TIME HEALING FROM BACK SURGERY DUE TO THE IPG LOCATION. IT WAS CAUSING PAIN AND DISCOMFORT TO THE PATIENT. THE PATIENTS LEAD WAS FRACTURED AND WAS NOT GETTING ADEQUATE COVERAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A HARD TIME HEALING FROM BACK SURGERY DUE TO THE IPG LOCATION. IT WAS CAUSING PAIN AND DISCOMFORT TO THE PATIENT. THE PATIENTS LEAD WAS FRACTURED AND WAS NOT GETTING ADEQUATE COVERAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589866 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5043111 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention