MEDTRONIC NAVIGATION, INC MAIN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC
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Model Number 9735665 |
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 11/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9735736.No parts have been returned for analysis.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 the system was intermittently tracking during the procedure.The site swapped to different instruments and the issue did not resolve.The spheres were confirmed to be cleaned.It was noted that there was a c-arm in the room in a lateral position, and the same height as the instruments.There was no impact on the patient out come as a result of this issue.The surgeon proceeded without navigation to complete the procedure.
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Manufacturer Narrative
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H2, h3, h6: software logs were received and evaluated by the medtronic sw analysis team.Analysis found that there was insufficient information to determine root cause of the reported behavior.Evaluation codes that apply to this analysis: 10, 213, 4315.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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H2: additional information received from the medtronic representative at the site stated that the system and instruments involved in this event have been used many times since and there have been no issues.It is believed that the actual spheres or another external influence that day caused the issue.H3, h6: a medtronic representative went to site and performed a system checkout.There were no failures found and the system passed checkout.Evaluation codes that apply to this analysis: 10, 213, 67.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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