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 gender of the baseline characteristics is male and the baseline age is 59 years old.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.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: predictors of arrhythmic events detected by implantable loop recorders in renal transplant candidates.Arq.Bras.Cardiol.2015;105(5):493-502.(b)(4).
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A journal article was reviewed which contained information regarding implantable loop recorders (ilrs).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article was about the "incidence and predictors" of patient who were renal transplant candidates and the use of ilrs.The article stated that there was a report of infection in which the ilr was removed.There were reported nonfatal major cardiovascular events which included acute pulmonary edema (9 patients), acute myocardial infarction (2 patients), acute peripheral vascular disease (2 patients), and ischemic stroke (1 patient).In addition, 14 patients underwent renal transplantation.The status of most of the ilrs is unknown.No patient complications have been reported as a result of this event.
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