Model Number S7 |
Device Problems
Device Inoperable (1663); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2018 |
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 hardware, software, and instruments passed the system checkout.The imaging system then passed the system checkout and was found to be fully functional.
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Event Description
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Medtronic received information regarding a navigation device being used for a catheter placement procedure intra-operatively.It was reported that the surgeon had registered the patient using a computed tomography (ct) image while in navigation.A magnetic resonance imaging (mri) was then brought into the room and the surgeon went to download it.He selected "unstructured" and noticed it was too big to load.He then decided to continue to navigation without the mri.When the surgeon tried going back into navigation, the registration was lost.Navigation was then aborted at this point.Surgery was delayed for 10 minutes with no impact to patient outcome.
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Manufacturer Narrative
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The exam from the procedure was sent to medtronic for evaluation.Testing was unable to replicate the reported issue.
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Search Alerts/Recalls
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