BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18373314 · Received December 21, 2023

    Report

    Report Number
    3006630150-2023-08037
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7091574. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 579993.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS INCISION AND DRAINAGE OF INFECTED SURGICAL SITE FROM HER CERVICAL SPINAL CORD STIMULATOR. THE INCISION OVER THE IPG APPEARS WELL-HEALED WITH NO DRAINAGE, THE MIDLINE INCISION DOES HAVE A RAISED AREA WITH MINIMAL DRAINAGE. HER STAPLES WERE REMOVED WITHOUT COMPLICATION AND THERE ARE NO MAJOR OPENINGS. SHE DOES REMAIN TENDER ALONG AND AROUND THE MIDLINE INCISION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168352 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7091518 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention