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

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  Injury  

Event Description

This mdr is being filed as the result of an update to our adverse event reporting procedure.The event occurred on (b)(6) 2022 but due to the new criteria, the awareness date is (b)(6) 2022.

Manufacturer Narrative

The device was originally prescribed to monitor arrhythmia associated with the symptom of syncope and collapse.The patient was hospitalized during the prescribed wear period.Specific information regarding when and for what reason the patient was admitted is not available.The device was returned and a final report was generated.When compiling the final report, a delayed mdn (md notification) for the first documentation of atrial fibrillation occurred on 5/19/2022, prior to the information regarding the hospitalization.This mdr submission represents an incident where the patient was hospitalized.The investigation revealed the device did not malfunction, it is unknown whether the use error caused or contributed to the hospitalization.This mdr is being filed out of an abundance of caution.

• 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: 16269337
• MDR Text Key: 308440901
• Report Number: 3007208829-2023-00017
• 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: 12/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/14/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2022
• Date Manufacturer Received: 12/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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: 91 YR
• Patient Sex: Male