Model Number 9733856 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information not provided due to (b)(6) patient privacy regulations.A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Other relevant device(s) are: product id: 9733686, serial/lot #: unk.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 that, while in a procedure, the navigation system was intermittently tracking instruments.It was reported that the tool cards were displayed to be disconnected while the camera was connected.It was noted that 17 tool cards had been selected to the procedure.There was no reported impact on patient outcome.
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Event Description
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Medtronic received information that the issue occurred during a posterior lumbar fusion.It was reported that the navigation system was rebooted multiple times when the surgeon was not actively using the navigation system.It was reported that the camera connection would return by waiting 4-10 seconds and that the navigation system was used to complete the procedure.The procedure was reported to have been delayed 1-2 minutes by the reported issue.
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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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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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Event Description
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Additional information received indicated the site had not used the system for a spine case since the reported error occurred.
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Search Alerts/Recalls
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