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

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

Patient Problem Arrhythmia (1721)

Event Date 10/17/2021

Event Type  Death  

Event Description

The patient suffered a fatal cardiac event during mobile cardiac telemetry monitoring.

Manufacturer Narrative

The patient expired on (b)(6) 2021, after approximately 13.33 days of the prescribed 14-day wear-period.There were ecg transmissions sent to the prescribing physician as part of routine and daily reports on october 8th, 11th, and 13th, 2021.These reports included episodes of ventricular tachycardia (vt) which were appropriately detected and transmitted by the medical device to the independent testing facility (idtf).According to irhythm technologies, inc.'s chief medical and chief scientific officer, the time for medical intervention would have been appropriate as early as october 8, 2021.Investigation into the reported issue has confirmed the device did not malfunction.The available evidence and investigation does not reasonably suggest the device caused or contributed to the reported death.Summary reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience.The zio at ecg monitoring system is not intended for use on critical care patients.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.

• Brand Name: ZIO AT PATCH
• 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 ave.; suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st; suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15481268
• MDR Text Key: 300547301
• Report Number: 3007208829-2022-00041
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00869770000210
• UDI-Public: 869770000210
• 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,Followup
• Report Date: 09/29/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 01/12/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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): Other; Death
• Patient Age: 78 YR
• Patient Sex: Male