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

Device Problems Failure to Transmit Record (1521); Adverse Event Without Identified Device or Use Problem (2993); Missing Test Results (3267)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 08/01/2022

Event Type  Death  

Event Description

The patient experienced an arrhythmia that was not detected by the device¿s automatic detection feature and was subsequently not transmitted during the wear-period. the event was found when compiling the final, full-data report by certified cardiographic technician. the patient was hospitalized and on (b)(6) 2022, it was confirmed by the account that the patient had expired due to ventricular tachycardia.The date of the patients death is unknown.

Manufacturer Narrative

The device has been returned to the investigation facility and an investigation is underway.A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

On (b)(6) 2022 the patients zio at device was placed.On 01aug2022, irhythm received an automated ticket indicating possible connectivity issues with the involved device.The patient was contacted to troubleshoot and was determined to likely be experiencing cell-connectivity issues associated with carrier coverage in the area.During the call, the patient was advised to continue wearing the device and to keep the gateway with them if traveling, as the device is designed backup unsent notifications in order to be sent in the event that it is able to obtain a cellular signal.Irhythm agents attempted to reach the account to notify them that the customer was experiencing coverage issues and this is likely the reason they were receiving no notifications and had not received a baseline report; however no contact was made.The device continued to work as an ecg monitor, but lacked cellular transmission functionality.No further transmissions were received after 01aug2022.On 17aug2022, the device was returned to irhythm, and the data was processed for inclusion on the final report.On 22aug2022, irhythm was made aware by the account that the patient was found by ems with pulseless vt and taken to the hospital (date of event not known as it occurred after the wear-period).On 26aug2022, the account confirmed the patient expired at an unknown date.An analysis of the diagnostic data was completed 14oct2022 and confirmed the gateway became idle and ceased connections on 29jul2022.The account alleged that the outcome could have been prevented by notification of the missed mdn.The zio at device is not a intended for monitoring of critically ill patients.

Event Description

The patient suffered a fatal cardiac event during mobile cardiac telemetry monitoring.An episode of ventricular tachycardia (vt) occurred during the wear-period but was not transmitted to irhythm servers.

• 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: 15459899
• MDR Text Key: 300293951
• Report Number: 3007208829-2022-00042
• 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: Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/04/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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: 90 YR
• Patient Sex: Male