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Model Number PED-275-14 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Infarction, Cerebral (1771); Intracranial Hemorrhage (1891)
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Event Date 08/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received reported that the patient had a right sylvian ischemic stroke, possibly related to the device and not related to the procedure which occurred on (b)(6) 2020.An mra was performed which showed 3 small acute ischemic lesions subcortical of the right upper frontal love.The event happened in the context of a recent change in antiplatelet medication in which plabix was stopped, and restarted after the event which was resolved on (b)(6) 2020.
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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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Additional information received noted that the patient's right sylvian ischemic stroke was not related to procedure/dapt, possibly related to device.The patient also had a silent asymptomatic cerebral infarction noted as not serious, possibly related to device, and not related to procedure/dapt.
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Search Alerts/Recalls
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