Livanova received a medwatch report mw#(b)(4) about a patient fainted 3 times in (b)(6) 2017 on different days.The patient also had significant fatigue and shortness of breath.In (b)(6) 2018 the patient began to have diarrea, vomiting and stomach pain and presented to the hospital.The patient was discharged home with zofran.One week later patient's vomiting persisted and re-presented to the hospital where an echo was performed and was found to have severe dilatated cardiomyopathy and a calculous cystitis.Serial echo demonstrating poor cardiac output and the patient was ultimately listed as needing heart transplant.An lvad was required due to his rapid decompensation along with intubation.Within the report preexisting characteristics that may have contributed to the event are listed: coronary heart desease, allergies to povidone iodine, shellfish allergy, measles mumps and rubella virus vaccine live, varicella virus vaccine live.In the report the event date is (b)(6) 2018 with no specific day and for this reason the data of event is not filled out.
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