BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17566485 · Received August 17, 2023

    Report

    Report Number
    3006630150-2023-04841
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7120287.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS WAS EXPOSED THROUGH THE SKIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS WAS EXPOSED THROUGH THE SKIN. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO SKIN BREAKAGE AT THE LEAD SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963241 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7120034 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention