MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INSTRUMENT TRACKER, EM ENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Catalog Number 9733533 |
Device Problems
Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect em tracker.No parts have been received by manufacturer for analysis.Part not received by manufacturer.
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Event Description
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A medtronic representative reported that, while in a procedure, their em tracker experienced a recognition failure.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome reported.
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Manufacturer Narrative
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Additional information: a medtronic representative reported that according to the rep the tracker was able to be recognized after the report event.The site declined to return the device, and the lot number was unobtainable.The doctor refused to provide patient information.
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Search Alerts/Recalls
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