Udi and manufacture date not available for this instrument at time of filing.A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced in the system.
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Medtronic received information regarding a navigation device being used for an electrode and probe placement procedure.The event occurred intraoperatively during the navigate task and delayed surgery by less than one hour.It was reported that during a deep brain stimulation (dbs) case with the stereotactic frame, the site lined up the target guidance view and tightened the stereotactic frame device.The entry was then reset to the probe tip location and upon doing so, the target guidance view became off.The target guidance view was on the screen as a 1 up view and showed the target had moved by 2 inches (zoomed in view, not 2 anatomical inches, but 2 inches on the surgeon monitor).The surgery was completed with the navigation device and there was no impact on patient outcome.
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