MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC
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Model Number 9733856 |
Device Problems
Human-Device Interface Problem (2949); Material Integrity Problem (2978)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 12/10/2019 |
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.Other relevant device(s) are: product id #: 9680152.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 outside of procedure.It was reported that the spin did not transfer to the navigation system.It was noted that the first spin was performed and was interrupted due to the connection with the imaging system.The bulkhead was then bypassed and the network cable was plugged directly into the computer of the navigation system.The site re-spun but the exam still did not transfer.The site aborted the use of the imaging system.There was a less than 1-hour delay to the procedure and no impact on patient outcome.It was later noted that, after the first spin was done, someone tripped over the network cable which interrupted the transfer to the navigation system.This is also what damaged the bulkhead, after that, the spin would not transfer to the navigation system.A second spin was not acquired.
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Event Description
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Through additional follow-up, it was later noted that the site aborted navigation after the bulkhead was broken.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H3) a medtronic representative went to the site to test the system.It was identified the bulkhead network connection cord was pulled from the machine, which damaged the bulkhead connection cord.A new bulkhead was installed.The system was found to be fully functional.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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