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Catalog Number 1830717FRT |
Device Problem
Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2014 |
Event Type
malfunction
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Event Description
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A medtronic ent representative reported that, while in an ear, nose & throat (ent) procedure, the site alleged an inaccuracy with the navigated balloon.It was noted that it showed on the anterior side of the bone, instead of the posterior side.No further details, or specific measurement, were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Patient identifier not made available from the site.A medtronic representative, following-up at the site, reported that the balloon tip showed being in the sinus and then it showed on the other side of the bone of the sinus, not accurate.The sinus was a frontal sinus.No parts have been returned to manufacturer for analysis.
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Manufacturer Narrative
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A medtronic representative reported that the actual instrument used during the reported event had been discarded and was unavailable for evaluation.The medtronic representative went to the site to test the rest of the navigation equipment.The hardware, software, and instrumentation passed the system checkout.The system was found to be fully functional.The reported event was unable to be replicated by medtronic personnel.
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Search Alerts/Recalls
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