BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10426048 · Received August 19, 2020

    Report

    Report Number
    3006630150-2020-03500
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    September 5, 2019
    Report Date
    August 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2019. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5061795. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: (B)(4), MODEL: SC-1200, SERIAL: (B)(4), BATCH: 20651294.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. THE PATIENT WAS HAVING IRRITATION AT THE MIDLINE INCISION WHEN SITTING AGAINST HIS BACK DUE TO THE DEVELOPED TISSUE KNOT OVER THE LEAD. IT WAS ALSO NOTED THAT THE THERE WAS TENDERNESS AT THE MIDLINE INCISION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891079 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5061589 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention