The hcp account was notified on day 2 that the device had met the asymptomatic transmission limit, and a replacement device zio at patch and gateway was declined.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 22.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.Malfunction.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.
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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.Also, under the process in place at the time of this event, when a transmission limit had been reached, the zio at daily report would reflect that to the hcp account through ¿trigger off¿ icons.The hcp was notified that the device had met the asymptomatic transmission limit, prior to the noted arrhythmia, and the hcp chose not to accept a replacement device since the patient received a pacemaker.
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