BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12116522 · Received July 5, 2021

    Report

    Report Number
    3006630150-2021-03512
    Event Type
    Injury
    Date Received
    July 5, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW DAYS AGO FROM DATE MANUFACTURER WAS MADE AWARE. 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: 7091166 PRODUCT FAMILY: SCS-IPG-R-MRI UPN: (B)(4). MODEL: SC-1200 SERIAL: (B)(4). BATCH: 374397.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WHICH STARTED IN THE MIDLINE INCISION SITE. PAIN AND PUSS AT THE INCISION SITE WERE NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014018 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7090704 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention