MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC
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Model Number 9733856 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)
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Event Date 08/15/2019 |
Event Type
malfunction
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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 issue could not be replicated.The system then passed the system checkout and was found to be fully functional.Device manufacturing date is unavailable.Other relevant device(s) are: 9733686 synergy spine software.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 device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the site's second spin had failed to transfer.The site took one spin, navigated without issue, and when they took the second spin, it wouldn't automatically transfer.They were unable to manually transfer either.The site was able to complete the procedure with the first spin and the 2nd spin was not required.There was a less than 1-hour delay to the procedure and no impact on patient outcome.
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Manufacturer Narrative
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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.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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