This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.Patient information is limited due to confidentiality concerns.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.The gender of the baseline characteristics is male and the baseline age is 63 years old.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder.If information is provided in the future, a supplemental report will be issued.
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