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 gender/age characteristics is male/61 years old.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.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:"impact of body mass index on the outcomes of catheter ablation of atrial fibrillation: a european observational multicenter study." journal of the american heart association.2019.Doi: 10.1161/jaha.119.012253.If information is provided in the future, a supplemental report will be issued.
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