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

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Heart Problem (4454)

Event Date 01/02/2021

Event Type  Death  

Manufacturer Narrative

This mdr is being filed due to a retrospective review of complaints per new established criteria for adverse event reporting.The awareness date represents the date this complaint was identified as meeting the new criteria.A follow-up mdr will be submitted should new significant information be obtained relative to this event.This mdr submission represents an incident where the patient expired.The investigation revealed the device 's gateway was never activated by the patient and no transmissions were received during the wear period.Although the device was never activated, it is unlikely the use error caused or contributed to the end of life event.The data retrieved from the returned patch was downloaded and the data revealed cpr was initiated on the patient as recorded by the device.A final report was posted.This mdr is being filed out of an abundance of caution.

Event Description

Per an update to the criteria for reportable events, this mdr is being submitted.On (b)(6) 2022 a patient expiration was identified as part of a retrospective review.On (b)(6) 2021 it was reported that the patient expired.

• 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: 15969409
• MDR Text Key: 305354373
• Report Number: 3007208829-2022-00058
• 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
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/22/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2021
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2020
• 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; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male