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Model Number PED-400-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Intracranial Hemorrhage (1891); Ischemia (1942); Nausea (1970)
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Event Date 04/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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The report is submitted at this time based on new information received about the event.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 a report that the patient experienced headaches with nausea on (b)(6) 2020.An mri performed on (b)(6) 2019 also showed an acute ischemic cerebrovascular accident in the left middle cerebral artery territory.Additional information received reported that the main sub- and supratentorial brain structures were visualized in a series of brain mr images in axial, saggital, and coronary views, in ¿1 and ¿2-weighted images.No shifting of midline structures was found.No dropsy.A discrete area has been identified of subcortical ischemic changes in the posterior sections of the right frontal lobe, spreading from the posterior sections of the sylvian fissure.It was concluded that there was an acute ischemic cerebrovascular accident in the left middle cerebral artery basin.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for a saccular aneurysm located in the left ica c6.The aneurysm size of the first aneurysm treated was 13.9mm, and the neck size was 9.5mm.Additional information received reported the patient had undergone pipeline implantation of two pipeline devices, the first on (b)(6) 2019 and the second on (b)(6) 2019, to treat 3 aneurysms.On (b)(6) 2019, mri revealed acute ischemic cerebrovascular incident in the left middle cerebral artery.The event was not reported to be life threatening and there was no noted patient disability.However, it did result in prolonged hospitalization of the patient who was discharged on (b)(6) 2019.Assessment determined the event was unlikely due to the pipeline device(s) but had a causal relationship with the procedure.It was also noted that the event was probably related to the disease under study but not to any additional underlying patient disease or condition.
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Manufacturer Narrative
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B5.Updated with additional information received.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 reported the adverse event of ischemic stroke was determined to be a serious event which may possibly have been related to the device.
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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 reported that the event was noted to be recovering/resolving on (b)(6) 2021.
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Event Description
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Additional information received reported that the acute ischemic cerebrovascular accident recovered/resolved on (b)(6) 2021.
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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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Search Alerts/Recalls
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