It was reported that after an afib cryo case, a stroke occurred post procedure.The patient was complaining of left arm and leg weakness.The neurologist believed that the issue was caused by the patient having high blood pressure and cholesterol.A ct scan was performed, and it came out negative.Also, an mri was ordered but the results are not known.The patient was reported to be in stable condition.Additional information provided stated that the soundstar catheter was not introduced to the left side at any point during procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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