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).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: newer generation cryoballoon vs.Contact force-sensing radiofrequency ablation catheter in the ablation of paroxysmal atrial fibrillation.Her zschrittmachertherapie elektrophysiologie (pacemaker therapy electrophysiology).2021; 32:236¿243.Doi.Org/10.1007/s00399-021-00763-6.If information is provided in the future, a supplemental report will be issued.
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