Concomitant medical products: arctic front advance cardiac cryoablation catheter.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific patient or 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 has occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The gender of the baseline characteristics is male and the baseline age is 57 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.Referenced article: ¿pulmonary vein isolation with real-time pulmonary vein potential recording using second-generation cryoballoon: procedural and biophysical predictors of acute pulmonary vein reconnection.¿ running title: predictors of acute pulmonary vein reconnection.Pacing and clinical electrophysiology.2017.Doi.Org/10.1111/pace.13230.If information is provided in the future, a supplemental report will be issued.
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