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

Device Problem Failure to Transmit Record (1521)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/11/2023

Event Type  malfunction  

Event Description

The patient experienced an arrhythmia that met medical doctor notification (mdn)requirements that was not transmitted during the wear period.The investigation confirmed the zio at reached the asymptomatic maximum transmission limit described in the product labeling.The hcp account was notified that the device was approaching the asymptomatic transmission limit prior to reaching the limit, according to standard process, and a replacement device was shipped.Follow-up with the account confirmed they were already aware of the arrhythmia, no treatment was required, and no adverse events, such as death or serious injury, are known to have occurred.

• 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: 17942279
• MDR Text Key: 325758944
• Report Number: 3007208829-2023-00115
• 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
• Type of Report: Initial
• Report Date: 10/16/2023

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: 01/09/2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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: 90 YR
• Patient Sex: Male