This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/ (b)(6) years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: predictive value of premature atrial complex characteristics in pulmonary vein isolation for patients with paroxysmal atrial fibrillation.Archives of cardiovascular disease.2021.114; 122¿131.Doi.Org/10.1016/j.Acvd.2020.09.001.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports patients who experienced arteriovenous fistulae, retroperitoneal hematoma, cardiac tamponade requiring percutaneous drainage or surgical intervention, right diaphragmatic paralysis and periprocedural strokes.The status/ disposition of the catheters is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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