It was reported that post cryo ablation procedure, the patient had atypical chest pain for a few days, with mild shortness of breath.Oral medication was administered and the patient's hospitalization was extended.The case was already completed with cryo.It was noted that the patient's symptoms then resolved.The patient was part of the (b)(6) study.No further patient complications have been reported as a result of this event.
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It was reported that post cryo ablation procedure, the patient had atypical chest pain for a few days, with mild shortness of breath.The catheter 2af283/ 06498 was not returned for investigation.In conclusion, this is a case related to a clinical adverse event (chest pain).There is no indication of relation of adverse event to the performance and malfunction of the product.The catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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