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 female (b)(6) 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.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: genetic variants associated with atrial fibrillation and long-term recurrence after catheter ablation for atrial fibrillation in turkish patients.Anatolian journal of cardiology.2021; 25: 129-38.Doi:10.14744/anatoljcardiol.2020.44082.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding catheter ablation for atrial fibrillation (af).The article reports patients who experienced access site complications during the ablation procedure.There were cases of inguinal hematoma, retroperitoneal hematoma, and femoral arteriovenous fistula.The fistula was resolved with surgical repair and the others were treated with medication therapy.There were patients who developed cardiac tamponade which required pericardiocentesis and a patient with phrenic nerve palsy which continued post procedure for twelve months.The status/disposition of the devices is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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