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

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

Patient Problem Syncope/Fainting (4411)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.Investigation concluded that the arrhythmia was not transmitted during the wear period because the gateway experienced a hardware malfunction and was unable to communicate with the cell module.No adverse events such as death or serious injury are known to have occurred, however the healthcare provider (hcp) stated that there was a delay in installing a pacemaker, and the patient later experienced a syncopal episode.

Manufacturer Narrative

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.No adverse events such as death or serious injury are known to have occurred, however the hcp stated that there was a delay in installing a pacemaker, and the patient later experienced a syncopal episode.The device was activated and the next day, the gateway experienced a hardware malfunction and was unable to communicate with the cell module.On the same day, the patient experienced an arrhythmia that was not transmitted due to the gateway malfunction.Once the device was returned, a final report was generated on day 15, and the hcp was notified of the arrhythmia.On day 18, the patient experienced a syncopal episode and sought care at a hospital.On day 19, the hcp stated that the patient was sent to the emergency department for a pacemaker.This event is being reported per 21 cfr 803 as a product problem / malfunction.This report does not constitute an admission by irhythm 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.

• 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; 9494132147
• MDR Report Key: 17514498
• MDR Text Key: 321243943
• Report Number: 3007208829-2023-00039
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/09/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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 Age: 78 YR
• Patient Sex: Male