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Device Problem
Failure to Transmit Record (1521)
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Patient Problem
Unspecified Heart Problem (4454)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The zio at device was returned to rhythm, and the clinical data was downloaded.A review of the clinical data found that the patient wore the zio at device for 10 days of the 14-day prescribed wear period.Rhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 30.The investigation revealed a potential algorithm sensitivity issue with the device, as there were no errors or issues observed around the time the missed episode occurred.This event is being reported per 21cfr 803 as a product problem /malfunction.This report does not constitute an admission by rhythm that the product described in this report has any defects or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.
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Event Description
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The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The investigation revealed a potential algorithm sensitivity issue with the device.The healthcare provider (hcp) was immediately notified, and irhythm learned that the hcp was already aware of the patient's arrhythmia and was treating it.There were no delays in treatment, and no adverse events, such as death or serious injury, are known to have occurred.
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Search Alerts/Recalls
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