Continuation of d10: 429888 lead; 6935m62 lead, implanted: (b)(6) 2022.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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It was reported that the patient developed acute decompensated heart failure. it was noted that the patient was directly admitted to the heart failure intensive care unit (icu) due to shortness of breath and edema. per the patient daughter, the patient was feeling unwell for about four to six weeks with abdominal and legs edema, generalized fatigue and malaise. a chest x-ray revealed a possible atelectasis and superimposed infiltrates/infection or edema. there was trace pleural effusions versus pleural thickening and vascular redistribution that could be secondary to positioning or mild pulmonary venous hypertension. it was noted that there was a concern for the prosthetic mitral valve and the patient subsequently underwent a transseptal valve-in-valve transcatheter mitral valve with atrial septal defect closure. the patient was treated with intravenous (iv) medication and the cardiac resynchronization therapy defibrillator (crt-d) remains in use. the patient is a participant in a clinical study. no further patient complications have been reported as a result of this event.
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