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) years old.
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: efficacy of cryoablation in idiopathic and non-idiopathic atrial fibrillation patients.
2021.
122 (2).
89¿94.
Doi: 10.
4149/bll_2021_013.
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 cryoablation in idiopathic and non-idiopathic atrial fibrillation (af) patients.
The article reports patients that had pericardial effusion which required pericardiocentesis, groin complications, such as arteriovenous fistulas and pseudoaneurysms, which were treated surgically.
The status/disposition of the catheters and sheaths 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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