Model Number S7 |
Device Problems
No Display/Image (1183); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The event occurred intraoperatively during the select patient/acquire scans task and delayed surgery by less than one hour.It was reported that the navigation system was not tracking the imaging system trackers on one side but was able to track on the opposite side.The navigation system was rebooted, and the camera was able to track both trackers without issue.The surgery was completed with navigation and imaging.There was no impact on patient outcome.
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Manufacturer Narrative
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Additional information: unique device identification (udi) and device manufacture date provided.
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Search Alerts/Recalls
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