Model Number S7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.The system then passed the system checkout and was found to be fully functional.
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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.It was reported that while navigating, the device became unresponsive.The mouse was not moving.After rebooting, the site was able to proceed with case.Surgery was delay for less than an hour and there was no known impact on patient outcome.
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Manufacturer Narrative
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The logs for the navigation system were reviewed by medtronic personnel.An instance of logging ceasing was noted after an instrument was instrument was introduced into the surgical field.However, the logs provided no additional insight into the probable cause of the anomaly.
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Search Alerts/Recalls
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