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Model Number 9735602 |
Device Problems
Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 9731203.A medtronic representative went to the site to perform a system checkout.The emitter was replaced.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 being used during a functional endoscopic sinus surgery (fess).It was reported that the users were not able to see the tracker in the emitter details window.When going to the eminterface drive and noise had one fault, indicating needing a new emitter axiem break out, it had a 7 on it.During troubleshooting, the kink in the cord was straightened out and no faults presented.The procedure was delayed by less than one hour and there was no impact on patient outcome.
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Manufacturer Narrative
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H3: hardware analysis was completed on the returned field generator.No faults or failures were found and the reported issue could not be duplicated.The generator connected to a test system for an overnight burn-in test.The system remained in green status during all testing.Flexing the cable does not indicate any intermittent opens.Lot number is 0400007395.H6: b01, c19 and d14 apply to the analysis above.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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