Medtronic received a report that contrast agent exudation with bleeding was reported during 24-hour post-procedure crf computerized tomography (ct) images performed on (b)(6) 2023.Ct revealed left basal ganglia, thalamus, paraventricular and deep temporal lobe high density film.The patient had no obvious clinical symptoms.The rationale for relating the event to system or procedure was that surgery increases the risk of bleeding.The issue has not resolved/patient not recovered.This was not a recurrent or new stroke.This adverse event (ae) was not related to the disease under study, and not related to an underlying condition or disease.The ae did not result from a device deficiency.Modified rankin scale (mrs) score 0,national institutes of health stroke scale (nihss) 21.This event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life- threatening.The site assessed this event as not related to the study device and possibly related to the study procedure.Pre-procedure mtici score 0, post procedure mtici score 2c.Additional information was received reporting that on (b)(6) 2023 head computerized tomography (ct) examination showed cerebral edema with lateral ventricle compression, and mannitol dehydration reduced intracranial pressure.Maintain electrolyte balance, improve c irculation, reduce lipid and stabilize plaque.This adverse event (ae) was not related to the disease under study or an underlying condition.Ae did not result from device deficiency.The patient has not recovered and the issue has not resolved.The site assessed this event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life-threatening.The site assessed this event as possibly related to the study procedure.
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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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