Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific 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 occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age is male (b)(6).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.Referenced article: "clinical experience with a novel electromyographic approach to preventing phrenic nerve injury during cryoballoon ablation in atrial fibrillation." circ arrhythm electrophysiol.2014 aug;7(4):605-11.(b)(4).
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A journal article was reviewed that contained information regarding this ablation catheter.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reports that there were the following complications during the ablation procedures: cardiac tamponade requiring drainage, groin hematomas, arteriovenous fistula, transient ischemic attack (tia), and phrenic nerve palsy (pnp) which recovered within six months of the procedure.No further patient complications have been reported as a result of this event.Referenced article: "clinical experience with a novel electromyographic approach to preventing phrenic nerve injury during cryoballoon ablation in atrial fibrillation." circ arrhythm electrophysiol.2014 aug;7(4):605-11.
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