MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Application Program Problem (2880); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the system shuts down and pops up an internal error message.Then restarts itself without further apparent consequences.The next step was to install the newest version of the software. there was no patient involvement.
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Manufacturer Narrative
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H3,h6) no parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received stating that the internal error message that popped up was unknown.
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Manufacturer Narrative
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Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: 9736226, version #: 1.3.0 h2: additional information was added to b5 and e.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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