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

Device Problems Failure to Transmit Record (1521); Failure to Sense (1559)

Patient Problems Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/16/2022

Event Type  Injury  

Event Description

The patient experienced a 4.2 second pause 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.Due to the delay in the notification, the patient experienced a delay in treatment which resulted in the patient being hospitalized due to a syncopal episode.

Manufacturer Narrative

The investigation was unable to determine the cause of the reported issue.During the final report process an additional finding for doctor notification was found, which fell within notification criteria, but was not transmitted to the account.No other performance or functional issues were found around the time of the alleged event.

Manufacturer Narrative

The patient was hospitalized approximately 11 days after the prescribed wear-period due to experiencing a delay in treatment.A cardiac event that met the device¿s automatic detection feature occurred on (b)(6) 2022 at 02:07:21 pm, during the wear-period, however the event was not transmitted to irhythm servers.On 23-jul-2022, the device was returned to irhythm for processing.During processing of the final report, (b)(6) 2022 irhythm discovered the un-transmitted cardiac event; a 4.2-second pause.The account was notified later the same day.On (b)(6) 2022 the patient was hospitalized due to syncope/collapse and received a pacemaker on (b)(6) 2022.An analysis of the diagnostic data was completed and confirmed the device was consistently transmitting during the wear-period.The most likely cause of the missed episode transmission is a potential algorithm sensitivity issue.Per the patient¿s provider, this event caused a delay in treatment.The zio at ecg 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 and automatically detected arrhythmia events are transmitted to a monitoring center for reporting.After wear, a final report is generated based on beat-to-beat information from the entire ecg recording.It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience.It is not intended for use on critical care patients.

• 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 avenue, suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15307613
• MDR Text Key: 298770333
• Report Number: 3007208829-2022-00045
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/06/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male