Concomitant medical products: achieve mapping 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.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The model listed in the report is a representative of the model family, as there is no specific model listed.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The baseline gender/age of the patients represented in the article is male/(b)(6) years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Referenced article: single freeze strategy with the second- generation cryoballoon for atrial fibrillation: a multicenter international retrospective analysis in a large cohort of patients.Journal of interventional cardiac electrophysiology.2017; 49(2):173-180.10.1007/s10840-017-0254-6.If information is provided in the future, a supplemental report will be issued.
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