BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 9710239 · Received February 14, 2020

    Report

    Report Number
    3006630150-2020-00567
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 24, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-8120-70 (SN: (B)(6)). DEVICE EVALUATION INDICATED THAT THE ALLEGATION OF THE LEAD HAVING A FRACTURE COULD NOT BE CONFIRMED SINCE ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS. CLEAN CUT DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE. THE RETURNED PADDLE LEAD EXHIBITED EXTENSIVE DAMAGE. VISUAL INSPECTION REVEALED THAT LEAD BODY WAS CLEANLY CUT APPROXIMATELY 11 CM FROM THE PROXIMAL END. ONLY ONE CLEAN CUT LEAD TAIL WAS RETURNED. THE OTHER LEAD TAIL AND THE PADDLE WERE NOT RETURNED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A FRACTURED LEAD. THE PHYSICIAN BELIEVED THAT THE LEAD WAS FRACTURED PRIOR TO SURGERY AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A FRACTURED LEAD. THE PHYSICIAN BELIEVED THAT THE LEAD WAS FRACTURED PRIOR TO SURGERY AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173701 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 216404A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention