Concomitant medical device(s): 4968-60 lead, implanted: (b)(6) 2008.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 during use of the cardiac resynchronization therapy defibrillator (crt-d) the patient was in the hospital with endocarditis.Cultures performed identified the organism as methicillin-resistant staphylococcus aureus bacteremia with involvement of the defibrillator lead and the tricuspid valve.The patient was diagnosed with septic shock, severe sepsis with acute kidney injury and left lower extremity ischemia.A transesophageal echocardiography (tee) was performed and noted small free mobile structure present on the aortic prosthesis and could not rule out vegetation.There was also a concern for aortic, mitral and device vegetation.The patient was treated with antibiotics and the crt-d system was subsequently explanted three days later.It was also reported, following the crt-d system extraction, at an unspecified time the patient was intubated with acute hypoxemic respiratory failure found to have septic emboli cerebrovascular accident (cva).The patient expired two days post explant of the crt-d system.The patient is a participant in a clinical study.
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