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

Model Number A100A100X

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

Patient Problem Arrhythmia (1721)

Event Date 04/20/2022

Event Type  Injury  

Event Description

This mdr is being filed in response to mw5109605.The patient suffered a cardiac event during mobile cardiac telemetry monitoring.

Manufacturer Narrative

The zio at ecg ambulatory monitoring system is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ecg) information for long-term monitoring.While continuously recording patient ecg, both patient-triggered (symptomatic) and automatically detected (asymptomatic) arrhythmia events are transmitted to an independent diagnostic testing facility (idtf) for monitoring and reporting.After wear, a final report is generated based on beat-to-beat information from the entire ecg recording.Below is a timeline of events supported by data obtained from the subject device: the device was activated on (b)(6) 2022 (and worn for approximately 5.5 days of the 7-day prescribed wear-period.) for four days, the device transmitted 500 transmissions.During these four days, the following md notifications occurred by the idtf.Several mdns and daily reports were provided to the account until the max trigger limit was reached on (b)(6) 2022.Each device will transmit up to 500 asymptomatic cardiac events.This constraint is necessary to preserve battery life for the full intended wear-period.Patient-triggered symptomatic transmissions are still able to be transmitted beyond this limit by pressing the large central button located on the outer device housing.This does not constitute a malfunction of the device as the device is functioning as designed.The account was notified the device was approaching the asymptomatic transmission limit on (b)(6) 2022 and a replacement device was dispatched to the customer overnight on (b)(6) 2022.On (b)(6) 2022, the patient experienced ventricular tachycardia (vt) and syncope.On (b)(6) 2022, the patient contacted irtc and indicated they would not wear the replacement device.The device was received by irtc on (b)(6) 2022.On (b)(6) 2022, after the receipt and analysis of final report data by the prescribing physician who confirmed the patient had been hospitalized (admission date is not known) and stable.Investigation into the reported issue has confirmed that the device did not malfunction.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
• 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: 15481445
• MDR Text Key: 300590128
• Report Number: 3007208829-2022-00048
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00869770000210
• UDI-Public: 00869770000210
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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 Operator: Lay User/Patient
• Device Expiration Date: 09/28/2022
• Device Model Number: A100A100X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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): Other; Hospitalization; Death
• Patient Age: 79 YR
• Patient Sex: Male