Model Number S7 |
Device Problems
Computer Software Problem (1112); 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 12/04/2017 |
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 inspected the navigation system onsite and after attempting to log in to the cranial application the system locked up on a black "loading.Please wait" screen.The system required a hard reset.On the second attempt it took 20 minutes to log in to the cranial software and the system locked up on the registration screen.The representative uninstalled and reinstalled the cranial software.The system loading issue persisted after the uninstall, reinstall.The computer was replaced and the issue resolved.A full navigation system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.The suspect computer has been returned to the manufacturer for evaluation, however results are not available at this time.
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Event Description
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A medtronic representative reported that while outside of a procedure, the navigation system unexpectedly shut down.While setting up for a case, the navigation system would repeatedly shut down unexpectedly when attempting to set up the points for a point merge registration.It was reported that the site could enter the cranial software, but upon adding points, the monitor would go black and the system would shutdown.There was no patient present when this issue was observed and the site used a second navigation system to complete cases.
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Manufacturer Narrative
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The analysis on the computer of the navigation system was completed by medtronic personnel.Testing found that the hard drive had 4095 reallocated sectors.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The logs for the navigation system were reviewed by medtronic personnel.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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