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Model Number 9733560XOM |
Device Problems
Material Integrity Problem (2978); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 9731203, serial/lot#: unknown.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 system.It was reported the system displayed an electromagnetic localization system communication error.The site rebooted the system multiple times with no change.While troubleshooting, the em interface testing status page displayed one fault code on the second drive line, indicating a faulted emitter, and the power page were all listed as okay, indicating the electromagnetic localization system was functioning normally.They went back into application and with emitter disconnected the electromagnetic localization system displayed as green status which confirmed the emitter faulted.This issue was noted outside of a procedure, and there was no patient involvement.
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Search Alerts/Recalls
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