BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 18750275 · Received February 21, 2024

    Report

    Report Number
    3006630150-2024-00865
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    December 24, 2023
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779919
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350 MODEL: SC-3138-35 SERIAL: (B)(6). BATCH: 7083099 PRODUCT FAMILY: SCS-NON-SURG ACC UPN: M365SC41080 MODEL: SC-4108 BATCH: 31695048.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED THAT THE REASON FOR THE REVISION WAS TO MAKE SURE THAT NOTHING WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602977 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 7074777 08714729779919

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention