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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Medtronic received a report that on (b)(6) 2023, post procedure ct revealed a new infarction in the left parietal insular lobe and a new infarction in the left occipital lobe without obvious symptoms.There was no treatment or actions taken.The outcome was not recovered/not resolved.The event was not a recurrent or new stroke and didn't result from a device deficiency.The event was possibly related to the disease under study and underlying condition or disease.The mrs score was 0 and nihss score was 6.Pre-procedure mtici was intermediate and post procedure mtici score was 3.The site assessed the eventas not related to the devices or procedure, however, the sponsor assessed the event as possibly related to the procedure and devices utilized.Additional information was received that a rebar was also used.
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