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 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/65 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: clinical predictors for bradycardia and supraventricular tachycardia necessitating therapy in patients with unexplained syncope monitored by insertable cardiac monitor.Clinical cardiology.2021;1¿9.Doi: 10.1002/clc.23594.If information is provided in the future, a supplemental report will be issued.
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