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Model Number 9735665 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 9735740, serial/lot #: (b)(4).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 an imaging system that was used during a sacroiliac and thoracolumbar procedure.It was reported that when trying to acquire scans from the imaging system, they were unable to get a green box for the trackers.However, when they opened the tracking view, they were able to see the purple leds of the trackers.At this point, the surgeon did not want to waste time troubleshooting.They decided to abort use of navigation and medtronic imaging, and proceed with another imaging system (c-arm).There was a reported delay of less than one hour and no known impact on patient outcome.
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Event Description
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Additional information was received.It was reported that the cause of the issue was suspected to be a glitch or user error. it was noted that the site has been using the system for weeks without issues.
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Manufacturer Narrative
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Additional information was received, see event date.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 software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.H6: additional review indicated codes b17 and c20 are no longer applicable to the event.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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2020-dec-14 , (b)(4) medtronic received information regarding an imaging system that was used during a sacroiliac and thoracolumbar procedure.It was reported that when trying to acquire scans from the imaging system, they were unable to get a green box for the trackers.However, when they opened the tracking view, they were able to see the purple leds of the trackers.At this point, the surgeon did not want to waste time troubleshooting.They decided to abort use of navigation and medtronic imaging, and proceed with another imaging system (c-arm.There was a reported delay of less than one hour and no known impact on patient outcome.2021-jan-14 e1 (rep) additional information was received.It was reported that the cause of the issue was suspected to be a glitch or user error. it was noted that the site has been using the system for weeks without issues.
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Search Alerts/Recalls
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