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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2023

Event Type  Death  

Manufacturer Narrative

A review of this complaint discovered that the patient was prescribed a zio at device.On day 11 irhythm called the patient to follow up on the ¿no connection¿ status, and irhythm was informed that the patient had expired on day 9.No further information regarding the patient¿s cause of death was provided.The zio at and gateway were not returned to irhythm for evaluation.Available device data indicates that the patch was removed from the patient on day 10.There were no known malfunctions to have occurred.There were actionable arrhythmias identified that did meet medical doctor notification (mdn) criteria during the patient¿s wear time and the account was notified.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.This event is being reported out of an abundance of caution.

Event Description

The patient expired during their prescribed zio at wear period.Irhythm attempted to gather more information about the cause of death from the account, but no further details were provided.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, IN; 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: 18450646
• MDR Text Key: 332173826
• Report Number: 3007208829-2024-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/03/2024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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 Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Female