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Model Number 9735665 |
Device Problems
Imprecision (1307); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The representative went out to service the system, and found that the tests passed, system works as intended and there were no parts 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 used in a cranial resection procedure.It was reported that they were unable to track instruments in navigate, but they were able to get through registration.The passive planar was flickering in tracking view, the representative noticed that spheres were not medtronic and grabbed medtronic spheres.The surgeon aborted the navigation before the representative returned.Once they swapped the probes there were no further tracking issues.It was also reported that the surgeon felt a 3 mm inaccuracy after going sterile.It was suggested that the representative would check the drape underneath the sterile frame after the case.There was less than 1 hour delay in the surgery and there was no reported patient outcome at the time of the event.
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Manufacturer Narrative
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H2) additional information: see b5.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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Event Description
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Medtronic received additional information that the suspected cause of the frame not being able to track was related to the use of no n-medtronic spheres.It was also reported that the suspected cause of the alleged inaccuracy was related to the registration.The patient was a prone registration with fiducials on the forehead.A manufacturer representative was able to show the site that their area of interest in the posterior fossa fell outside of 2mm sphere of accuracy.
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Search Alerts/Recalls
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