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 the site to test the equipment.Testing revealed that the computer of the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information that, through a site representative, the navigation system became unresponsive while outside of a procedure.It was noted that the issue occurred when transferring an image from a planning system.It was suspected that the scan used was the probable cause of the anomaly as the site was using the navigation system without issue on other exams.There was no patient present when this issue was identified.No additional information was provided.
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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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