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/60 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: radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation: durability of pulmonary vein isolation and effect on atrial fibrillation burden the race-af randomized controlled trial.
Circulation: arrhythmia and electr ophysiology.
2021;14:e009573.
Doi: 10.
1161/circep.
120.
009573.
If information is provided in the future, a supplemental report will be issued.
|