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

Device Problem Data Problem (3196)

Patient Problem Atrial Fibrillation (1729)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

The patient experienced symptomatic rapid af that was not detected by the device¿s automatic detection feature and was subsequently not transmitted during the wear-period.

Manufacturer Narrative

An automated ticket for a suspected leads-off condition was generated and upon follow-up the customer communicated the device had been removed because they had a pacemaker placed and had just been released from the hospital following pacemaker placement surgery.The device was returned to irhythm for processing and an additional finding of rapid af was identified while compiling the final report which was not transmitted during the wear-period.The patient¿s physician, however, had recommended she visit the er based upon a rapid af notification due to a second event, which was transmitted to the account as designed shortly after the missed event.An analysis of the diagnostic data was completed and attributed the missed episode to bluetooth communication issues between the patch and gateway.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
• 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, CA 94103 ; 9494132147
• MDR Report Key: 15771299
• MDR Text Key: 307775908
• Report Number: 3007208829-2022-00051
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/18/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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: 73 YR
• Patient Sex: Female