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 Patient Involvement (2645)
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Event Date 03/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.Representative reported that the site had performed cases without any issues.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 while outside of procedure, when the surgeon loaded an archive scan from cranial application, the navigation system became unresponsive after advancing to registration task from planning stage.It was reported that the system then worked but after registration the system became unresponsive in navigation.Surgeon used another navigation system but had the same issue.There was no patient present at the time of the issue.
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Manufacturer Narrative
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The computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
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Search Alerts/Recalls
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