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 08/05/2023

Event Type  malfunction  

Event Description

The patient experienced an arrhythmia that met medical doctor notification (mdn)requirements that was not transmitted during the wear period.The investigation confirmed the zio at reached the asymptomatic maximum transmission limit.The hcp account was notified that the device was approaching the asymptomatic transmission limit prior to reaching the limit, according to standard process, and a replacement device was declined.Due to the patient¿s arrhythmia frequency, the physician ordered an additional diagnostic test.The results of the additional testing are unknown.No treatment was required, and no adverse events, such as death or serious injury, are known to have occurred.

Manufacturer Narrative

The patient experienced an arrhythmia that met medical doctor notification (mdn)requirements that was not transmitted during the wear period.The investigation confirmed the zio at reached the asymptomatic maximum transmission limit.No treatment was required, and no adverse events, such as death or serious injury, are known to have occurred.The patient initiated two symptomatic transmissions and wore the device for 13 days of the 14 days prescribed.The device last transmitted and reached the maximum transmission limit eight days after it was activated.The healthcare provider (hcp) account was notified on day 6 that the device was approaching the asymptomatic transmission limit, and a replacement device was declined.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 21.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 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 21cfr 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.

• 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: 17729922
• MDR Text Key: 323191792
• Report Number: 3007208829-2023-00049
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/26/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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: 35 YR
• Patient Sex: Male