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Model Number UNK-NV-ECHELON |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hydrocephalus (3272); Syncope/Fainting (4411)
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Event Date 11/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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Associated with mdr #: 2029214-2023-00016.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.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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Medtronic review of the literature article found that a 72-year-old female patient presented with disturbance in consciousness.Computed tomography (ct) revealed a diffuse subarachnoid hemorrhage.Magnetic resonance angiography (mra) and digital subtraction angiography revealed a ruptured aneurysm in the basilar top accompanied by a right aortic arch.Coil embolization was performed for this ruptured aneurysm with a combination of the balloon-assisted technique with a hyperform 4x7mm balloon catheter and double-catheter technique in which an echelon-10 microcatheter was used for coil embolization on day 1.Postoperative digital subtraction angiography (dsa) showed no aneurysm, and she did not suffer from symptomatic vasospasm.The procedure was considered successful to resolve the aneurysm.There were no device malfunctions or intraoperative issues noted.However, post-operatively, the patient was affected by consciousness disturbance due to hydrocephalus.Hence, a ventriculoperitoneal shunt procedure was performed to treat the patient's hydrocephalus on day 35.The patient was discharged and her subsequent postoperative course was uneventful.
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Manufacturer Narrative
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B5.Updated with additional information received.Associated with mdr #: 2029214-2023-00016 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 ported the adverse events reported in the article were not related to the medtronic devices used in the procedure.
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Search Alerts/Recalls
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