MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 9736226, serial/lot #: software version: (b)(4).Software analysis determined that this was a known software issue tracked in a medtronic database.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 outside of a procedure.It was reported that when booting on the system, the splash screen would remain for several minutes and not proceed into the software.The manufacturing representative (rep) restarted the system and it resolved his issue, he was able to log into the system.There was no patient present when this issue occurred.It was reported that directly from the login/keyboard screen, it went to a black screen that said medtronic and stayed like that.
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Search Alerts/Recalls
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