BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18166947 · Received November 18, 2023

    Report

    Report Number
    3006630150-2023-07172
    Event Type
    Injury
    Date Received
    November 18, 2023
    Date of Event
    October 25, 2023
    Report Date
    April 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7092031.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REPORTS THAT HE HAD AN INJURY THAT CAUSED A WOUND NEAR MIDLINE LEAD SITE. HE HAS HAD SEROSANGUINEOUS DRAINAGE FROM WOUND AND MAIN COMPLAINT IS PAIN AND TENDERNESS AT THE WOUND SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142760 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7092019 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1