BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10250163 · Received July 9, 2020

    Report

    Report Number
    3006630150-2020-02832
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 9, 2020
    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

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7071244.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AT THE THORACIC INCISION SITE. SYMPTOMS INCLUDED SWELLING AND PUSS AT MIDLINE BACK INCISION. THE CAUSE OF INFECTION WAS UNKNOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712977 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7071243 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention