BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 9772386 · Received February 28, 2020

    Report

    Report Number
    3006630150-2020-00873
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 12, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-8120-70 (SN: (B)(6) ) DEVICE EVALUATION INDICATED THAT THE ALLEGATION OF THE PADDLE LEAD HAVING MULTIPLE OPEN CONTACTS WAS CONFIRMED. VISUAL AND X-RAY INSPECTION OF THE LEAD BODY REVEALED (B)(4) FRACTURED CABLES 18 CM FROM THE PROXIMAL END OF LEAD TAIL (B)(4) (ELECTRODE 1-8). THE (B)(4) LEAD BODIES HAVE DAMAGED INSULATION, EXPOSING THE CABLES AT THE FRACTURED SECTION OF THE LEAD. IT APPEARS THAT THE FRACTURED SECTION OF THE LEAD WAS DAMAGED BY SCRAPING OR WEARING AWAY OF THE LEAD INSULATION, CAUSING THE EXPOSURE OF THE INDIVIDUAL CABLES. CABLES WERE EVENTUALLY FRACTURED, AND IT RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO LEAD MIGRATION. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO LEAD MIGRATION. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234706 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 225449A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention