MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC
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Model Number 9735665 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 01/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.No devices were returned to the manufacturer for analysis.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 intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the site was taking a spin, but it was not able to transfer.The site had taken two spins, but neither had a nav tag.When they are beginning the spin, the navigation system is all green and no connections are lost during the spin.The site rebooted both units and re-spun, but the exam still doesn't have a nav tag.There was a less than 1-hour delay to the procedure and no impact on patient outcome.
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Manufacturer Narrative
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A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined as the behavior could not be replicated.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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H3: a medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system then passed the system checkout and was found to be fully functional codes associated with the system: fdr 213, fdc 67 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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