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 baseline characteristics of the patients referenced in the article is gender/age is female/(b)(6).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: once isolated, always isolated? incidence and characteristics of pulmonary vein reconduction after second-generation cryoballoon-based pulmonary vein isolation.Circ.Arrhythmia electrophysiol.2015;8(5):1088-1094.(b)(4).
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Heeger c-h, wissner e, mathew s, et al.Once isolated, always isolated? incidence and characteristics of pulmonary vein reconduction after second-generation cryoballoon-based pulmonary vein isolation.Circ.Arrhythmia electrophysiol.2015;8(5):1088-1094.The literature publication reports the following patient complications: one patient with procedure-related hematoma in which no intervention was taken.
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