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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 01/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The hcp account was notified on day 3 that the device had met the asymptomatic transmission limit, and a replacement device zio at patch and gateway was shipped.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 14.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 clinician to inform the clinician that a replacement zio at patch and gateway will be sent, unless a clinician representative determines a replacement is not needed.In keeping with fda¿s position on reporting expectations as communicated to the company in may 2023, irhythm aligned to a reporting approach for mdns that were not communicated during the wear period due to a maximum transmission limit being reach, and agreed to treat these instances as malfunction mdrs for reporting purposes.This report does not constitute an admission by irhythm that the product described in this report has any defects or has malfunctioned.Certain terms included in form fda 3500a and related mdr submission materials 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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No adverse events, such as death or serious injury, are known to have occurred.The patient experienced an arrhythmia that met the criteria for medical doctor notification (mdn) (arrhythmias of clinical interest during the product wear period) for the hcp location, but that was not conveyed to the hcp location during the wear period.The investigation confirmed that the zio at reached the asymptomatic maximum transmission limit for the zio at device, prompting a contact to the hcp account.Under the process in place at the time of this event, an approaching transmission limit and a transmission limit being reached would prompt contact to the hcp account, in tandem with precautions discussed in the labeling and ¿trigger off¿ icons presented to hcp accounts on the zio at daily reports when a transmission limit had been reached.The hcp was notified that the device had met the asymptomatic transmission limit, prior to the noted arrhythmia, and a replacement device was sent.
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Search Alerts/Recalls
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