Model Number S7 |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the select patient/acquire scans task and delayed the surgery by less than one hour.It was reported that a spin was taken but it was not transferring to the navigation device.The device was sitting on ¿waiting to acquire¿.The system was rebooted, and the spin was transferred.The surgery was completed with navigation and there was no 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 reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.
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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 behavior of the reported issue was found to be consistent with a known anomaly in the medtronic navigation software anomaly tracking database.This issue was documented in a medtronic navigation software anomaly tracking database.
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Search Alerts/Recalls
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