Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is approximately 56 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: ¿second-generation cryoballoon ablation for paroxysmal atrial fibrillation: predictive role of atrial arrhythmias occurring in the blanking period on the incidence of late recurrences.¿ heart rhythm.2016;0:-1¿7.(b)(4).
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Mugnai g, de asmundis c, hunuk b, et al.¿second-generation cryoballoon ablation for paroxysmal atrial fibrillation: predictive role of atrial arrhythmias occurring in the blanking period on the incidence of late recurrences.¿ heart rhythm.2016;0:-1¿7.The literature publication reported the following patient complication: there was one (1) patient with retro-peritoneal hematoma.No further patient complications have been reported as a result of this event.
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