Model Number 9733858 |
Device Problem
Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.Other relevant device(s) are: product id: 9733623, lot/serial #: unknown.Foreign country: (b)(4).No parts have been received by the manufacturer for evaluation.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.It was reported outside of a procedure that surgeon monitor shows black lines.No patient was present at the time of the event.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9733623, serial/lot: (b)(4), udi: (b)(4).A medtronic representative went to the site to test the equipment.The reported behavior was confirmed and the system monitor was replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a manufacturer representative indicated the reported issue was likely related to something hitting the monitor.
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Manufacturer Narrative
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Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9 733623, serial/lot #: (b)(6): h3) the monitor was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The returned monitor had been impacted on both sides shattering the display.The monitor was not usable as is.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.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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