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

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

Patient Problem Unspecified Heart Problem (4454)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

The zio at device was returned, and the and the clinical data was downloaded.A review of the clinical data found that the patient wore the zio at device for 13 days of the 14-day prescribed wear period.Irhythm became aware of the misclassified arrhythmia while preparing the final report and notified the hcp on day 24.The diagnostic data indicates that no functional issues were observed for the device around the time of the specified episode.Analysis of device logs found that the device performed as intended with no performance or functional issues noted.The investigation revealed that the certified cardiographic technician (cct) misclassified the event and the physician subsequently agreed with the cct interpretation of hgavb.The zio at clinical reference manual states in the ¿indications for use¿ section that ¿the reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience.¿ this event is being reported per 21cfr803 as a serious injury.This report does not constitute an admission by rhythm that the product described in this report has any defects, or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.This report is being filed in an abundance of caution.

Event Description

The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not communicated during the wear period.The investigation revealed that a preliminary ecg interpretation provided to the physician was misclassified.Following the wear period and while compiling the final report, the interpretation was amended.The healthcare provider (hcp) was immediately notified, and irhythm learned that the patient had received a pacemaker.It is unknown if the pacemaker was indicated by other symptoms and/or test results.Several good faith attempts were made to acquire additional information but with no result.

• 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: 18539610
• MDR Text Key: 333179360
• Report Number: 3007208829-2024-00026
• 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: 01/18/2024

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: 02/04/2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Male