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

Device Problems Use of Device Problem (1670); Wireless Communication Problem (3283)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/01/2021

Event Type  Death  

Manufacturer Narrative

The at patch and gateway were returned, and no malfunction was identified.The patient experienced a life-threatening arrhythmia which was not transmitted to irhythm¿s idtf (42cfr410) until after the patient expired.The time discrepancy between the real time occurrences and the data received by irhythm was most likely due to the patient not being near the gateway when admitted to the hospital.Not until the patch and gateway were in proximity were the events transmitted, which was after the eol event.

Event Description

This mdr is being filed as the result of an update to our adverse event reporting procedure.The event occurred on (b)(6) 2021, but due to the new criteria, the awareness date is 16dec2022.The patient passed way while wearing 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): RHYTHM 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: 16142575
• MDR Text Key: 307149590
• Report Number: 3007208829-2023-00002
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/27/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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: 35 YR
• Patient Sex: Male