MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Failure to Transmit Record (1521)

Patient Problem Unspecified Heart Problem (4454)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

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, and a replacement device was sent.

Manufacturer Narrative

The hcp account was notified on day 9 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 35.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 (b)(6) 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.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 17844128
• MDR Text Key: 324596981
• Report Number: 3007208829-2023-00099
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/03/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female