BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGHT ARC ON LAPTOP

    MDR report key: 10953966 · Received December 5, 2020

    Report

    Report Number
    1222895-2020-00001
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 13, 2020
    Report Date
    November 13, 2020
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K010548
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEURO SIGHT ARC WAS NOT RETURNED FOR EVALUATION (AS PER SALES REPRESENTATIVE, PRODUCT NOT AVAILABLE) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED FALSE COORDINATES IN THE NEUROSIGHT ARC ON LAPTOP (PRODUCT ID ST1000) DURING A DEEP BRAIN STIMULATION (DBS) PROCEDURE. THERE WAS NO SURGERY DELAY AND THE PROCEDURE WENT ON AS SCHEDULED AS THEY WERE NOT AWARE OF THE GLITCH. THE ISSUE WAS DISCOVERED WITHIN TWO (2) HOURS AFTER THE PROCEDURE WHILE REVIEWING A POSTOPERATIVE CT SCAN. THEY RECONSTRUCTED THE STEPS TAKEN WHILE USING THE SOFTWARE FOR SURGICAL PLANNING TO DISCOVER HOW THE GLITCH CAME ABOUT AND CHANGED THE USE OF THE SOFTWARE TO AVOID THE SEQUENCE OF STEPS CAUSING THE GLITCH FOR ALL FUTURE CASES. PATIENT SUFFERED NO ADVERSE MEDICAL EFFECTS FROM THE IMPLANT PLACED IN THE WRONG LOCATION, AND REVISION SURGERY WAS PERFORMED WITHOUT INCIDENT THE FOLLOWING MORNING TO CORRECT THE LOCATION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416656 NEUROSIGHT ARC ON LAPTOP N/A HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1