Model Number 9735665 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.No additional information has been provided/submitted to the manufacturer for an evaluation to be conducted.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system being used for an arteriovenous malformation (avm) procedure.It was reported that an error message was received on the system during the navigation task.The site registered using fiducials and a trace registration method.The whole head was covered with a 2-millimeter area.While adjusting the settings for the views and 3d models, error message 64 was received on the navigation system screen.This required a reboot.The site then switched to another medtronic navigation system to complete the procedure.There was a surgical delay of less than 15 minutes due to this issue, and there was no known or reported impact on patient outcome.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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