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.
|
It was reported that the patient called the healthcare professional office and reported chest pain unrelieved by acetaminophen and reported a ¿pop¿ every once in a while, during a heartbeat. it was noted that the patient experienced shortness of breath. patient was advised to go to the emergency department for evaluation. while in the emergency department, the patient had an ultrasound at bedside, and it revealed a pericardial effusion concerning for cardiac tamponed physiology. it was noted that an echocardiogram revealed a large circumferential pericardial effusion. the evidence suggestive of cardiac tamponade (right ventricular collapse). the patient reported chest pain and shortness of breath. a computerized tomography (ct) scan revealed a significant beam hardening artifact and a small to moderate hemopericardium with pericardial drain in place. another echocardiogram revealed a preprocedural and intraprocedural clips that showed a large pericardial effusion anterior to the heart with large echogenic mass in the pericardial space. the patient was also hypotensive requiring blood pressure support after no response from intravenous (iv). it was noted the interventional cardiology consulted and patient was taken to operating room for pericardiocentesis and pericardial drain placement. post procedural clips show no significant pericardial effusion. a calcium sensitizer was weaned post procedure and the device 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.
|