BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 17600696 · Received August 23, 2023

    Report

    Report Number
    3006630150-2023-04969
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779902
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 17374092.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEADS WERE DAMAGED AND CAUSED CONTACT PIECES TO SPREAD WITHIN THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496541 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 17374092 08714729779902

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention