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 03/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.Concomitant medical products: other relevant device(s) are: product id: 9733686, version 2.1.0.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 for a sacroiliac and thoracolumbar procedure.It was reported that during a case the surgeon felt inaccurate immediately after registration.The surgeon was using a mayfield and cranial reference frame.The surgeon felt off by 5mm deep.They attempted to resolved by re-spinning with the medtronic imaging system they were using for the case, but the new exam had the same issues.There was a reported delay of 10 minutes and no reported impact to patient outcome.Medtronic received information that the surgeon opted to complete the procedure compensating for the imprecision.
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Manufacturer Narrative
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Onsite functional and visual examination was performed by a manufacturer representative.The representative was unable to replicate the reported event.The system passed a system checkout and was returned to an operational condition.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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The procedure was a cervical spinal procedure.
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Manufacturer Narrative
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H3: software analysis completed.The logs were reviewed but provided no additional insight regarding the cause of reported complaint.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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Search Alerts/Recalls
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