Medtronic received information regarding a navigation device being used for a catheter-based procedure.
It was reported that, intraoperatively during the navigation task, there was an axiem tracking failure.
The surgeon registered correctly and navigation was accurate; registration was taken over the whole head as is recommended.
The surgeon marked the site for incision and burr hole.
After scrubbing, the surgeon used the stylet to navigate; when the surgeon moved the stylet to the entry point at the back of the head, the image went blank.
Navigation was accurate at the front of the head and accuracy maintained throughout.
Both the tracker and probe remained green and visible.
The surgeon stopped and unstopped navigation using the foot pedal and flicked through screens to try different things.
Eventually it worked but the surgeon was unsure how.
There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.
|