The patient had a concomitant surgical procedure of aortic valve replacement, ascending aorta replacement, maze and left atrial appendage (laa) ligation procedure through sternotomy.During the same procedure on (b)(6) 2022 a cryoflex probe powered by a cryo-console, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were achieved.Patient had been in junctional rhythm during the procedure and switched to ventricular paced rhythm, the next day on (b)(6) 2022.Patient switched back to junctional rhythm and stayed that way for 5 days until (b)(6) 2022. event was treated with medication and percutaneous intervention.The patient recovered.The adverse event was deemed by the sponsor as not related to the cryoflex probe, cardioblate lp clamp or ft-10 generator and related to the study procedure, concomitant procedure and cryo-console instrument.Medtronic received additional information that the adverse event was deemed by the site as possibly related to concomitant procedure, study procedure, cryoflex probe, and the cardioblate lp clamp.
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