Model Number S7 |
Device Problems
Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/08/2018 |
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 representative reported that creating a new procedure didn't resolve the issue.The loaded another patient and was able to get to plan without issue.Then they deleted and reloaded the patient and was able to get a plan.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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Event Description
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Medtronic received information regarding a navigation system outside of a procedure.It was reported that the cranial application was rebooting itself when going from the 'verify instrument' task to the 'plan' task.Four attempts were made to go from one task to the other but the system rebooted itself every time.The cd drive was empty.There was no patient present.
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Manufacturer Narrative
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Correction: serial number updated to proper value.
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Manufacturer Narrative
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A review of the logs found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
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Search Alerts/Recalls
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