Medtronic received information, that one day post implant the patient showed decline in their blood pressure.And as a result intravenous therapy (iv) began.Cardiogenic shock was suspected, due to tamponade.To rule out tamponade, the patient was brought into the operating room (or) for a re-thoracotomy.There was no overt bleeding or tamponade present.The patient then returned to the icu with iv inotropics and extracorporeal membrane oxygenation (ecmo).It was determined, that the cardiogenic shock was likely, due to stunning post cardiotomy.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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