The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements, that was not transmitted during the wear period.The zio at reached the asymptomatic maximum transmissions limit.No adverse events such as death or serious injury are known to have occurred.The device was worn for approximately 10 days of the 14-day prescribed wear-period.The device transmitted 432 asymptomatic events within the first 7 days, all which were transmitted and processed appropriately, resulting in several mdns.The hcp account was notified on that the device was approaching the asymptomatic transmission limit, and a replacement device was dispatched to the patient.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 15.As described in product labeling, the zio at device has a maximum threshold of transmitting 100 patient triggers and 500 asymptomatic transmissions during wear.When a patient is approaching the limit for either transmission type, irhythm reaches out to the account to determine whether to send another zio at device to the patient.Patient-triggered symptomatic transmissions are still able to be transmitted beyond this limit by pressing the large central button located on the outer device housing.This event is being reported per 21 cfr 803 as a product problem / malfunction.This report does not constitute an admission by irhythm 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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The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements, that was not transmitted during the wear period.Investigation confirmed that the zio at reached the asymptomatic maximum transmissions limit described in the product labeling.The hcp account was notified the device was approaching the asymptomatic transmission limit prior to reaching the limit, and a replacement device was dispatched to the patient, according to standard process.No adverse events such as death or serious injury are known to have occurred.
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