Model Number I7 |
Device Problems
Computer Software Problem (1112); Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.A medtronic representative went to site to test the equipment.Representative reported that uninstalling and reinstalling the cranial software resolved the issue and the site was not having any further issues at this time.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.
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Event Description
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A site representative reported that during a procedure, the navigation system was unable to track axiem instruments.Rebooting the system resolved the issue and site were able to track instruments.The procedure was completed with the use of navigation.No information was provided on delay to procedure.There was no known impact on patient outcome.
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Manufacturer Narrative
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The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
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Search Alerts/Recalls
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