BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12572450 · Received October 4, 2021

    Report

    Report Number
    3006630150-2021-05557
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    May 23, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7090357.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOME PURULENT MATERIAL CAME OUT FROM THE LEAD INCISION SITE AND THE PATIENT WAS TREATED FOR THE INFECTION BY THE EMERGENCY ROOM AND WOUND CARE. ANTIBIOTICS WERE PRESCRIBED. THE INFECTION WAS NOT PROCEDURE RELATED BUT DEVICE RELATED AND THE CAUSED WAS UNKNOWN. POST TREATMENT SHOWED THAT THE LEAD INCISION WAS OPENED AND WOUND WAS NOT HEALED WITH SOME SECRETION BUT IT WAS NO LONGER LOOKED INFECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465759 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7090132 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention