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 12/05/2023

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 the standard process, and a replacement device was declined.Irhythm was informed that the patient had received a pacemaker.There was no delay in treatment, and no adverse events, such as death or serious injury, are known to have occurred.

Manufacturer Narrative

The device was returned to irhythm, and the clinical data was downloaded.A review of the clinical data revealed the device was worn for 6 days of the 14-day prescribed wear period.The device reached the asymptomatic maximum transmission limit and stopped transmitting asymptomatic events on day 5.The hcp account was notified on day 4 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 19.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 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 94103
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 18492064
• MDR Text Key: 333140328
• Report Number: 3007208829-2023-00216
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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: 64 YR
• Patient Sex: Male