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 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The zio at reached the asymptomatic maximum transmissions limit.No adverse events such as death or serious injury are known to have occurred.The device was approaching the maximum transmission limit four days after it was activated.Irhythm contacted the patient¿s healthcare provider (hcp) to notify that the device was reaching the maximum transmission limit.After the third notification attempt, a second device was shipped to the patient.The following day, the hcp contacted irhythm and declined the second monitor to be sent since the patient was already in the hospital for non-cardiac related issues.The first patch device was returned and during preparation of the final report, irhythm became aware of an arrhythmia that occurred four days after the device had reached the maximum transmission limit.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 21 cfr 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.

Event Description

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.Investigation confirmed that the zio at reached the asymptomatic maximum transmissions limit described in the product labeling.The healthcare provider (hcp) account was notified the device was approaching the asymptomatic transmission limit prior to reaching the limit, and a replacement device was dispatched to the patient, according to standard process.No adverse events such as death or serious injury are known to have occurred.

• 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: 17778114
• MDR Text Key: 323807197
• Report Number: 3007208829-2023-00047
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/07/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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: 81 YR
• Patient Sex: Male