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

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2022

Event Type  Death  

Manufacturer Narrative

When compiling the final report, an arrhythmia which met notification criteria (mdn) for slow atrial fibrillation (slow af) was found.The mdn was delayed as it was not transmitted to irhythm servers during the wear-period.When account was contacted to provide notification of the missed event, irhythm was informed that the patient had expired.The account stated the cause of death was unknown.Each device is intended to be worn for a 14-day period and is capable of transmitting 500 asymptomatic episodes.The first device was registered (b)(6) 2022 in clinic but was not activated until (b)(6) 2022 despite multiple attempts to reach the patient and account.On the (b)(6) 2022, irhythm dispatched a replacement device, as the first device was approaching its transmission limit of 500 asymptomatic notifications, and the first device was removed the next day on (b)(6) 2022 (worn for 25 days).The second device (delivered on (b)(6) 2022) was returned unused.Due to the limited information available, unintended use error cannot be ruled as a potential contributing factor to the reported death.A device evaluation of the worn device was completed, and no functional issues were observed.

Event Description

The patient expired while using zio at.

• 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
• MDR Report Key: 16211913
• MDR Text Key: 307764877
• Report Number: 3007208829-2023-00005
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/12/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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 Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male