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/63 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: optimal single procedure strategy of pulmonary vein isolation with cryoballoon or radiofrequency and non-pulmonary vein triggers ablation for non-paroxysmal atrial fibrillation.Ijc heart <(>&<)> vasculature.40 (2022) 101021.Doi:10.1016/j.Ijcha.2022.101021.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 pulmonary vein isolation with cryoballoon ablation.The article reports patients who experienced complications such as cardiac tamponade, puncture site fistula, cerebral vascular disease which included cerebral infarctions or cerebral hemorrhages, and severe bleeding.It is unknown if any intervention was performed with any of these complications.The status/disposition of the catheters and sheaths 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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