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 Insufficient Information (4580)

Event Date 05/14/2023

Event Type  Death  

Manufacturer Narrative

The patient was prescribed a zio at device that was placed in clinic by their physician on (b)(6) 2023.Available device data indicates that the patch was removed from the patient on (b)(6) 2023.No actionable arrhythmia events were identified during the wear period.On (b)(6) 2023 irhythm called the patient to follow up on ¿no connection 24 hours¿ status, the patients son stated that the patient had expired.They also stated that the zio at device could not be located, therefore a device evaluation cannot be completed.No further information on the patients cause of death is known and the investigation cannot confirm if a malfunction has occurred nor if the device caused or contributed to the patients death.Out of an abundance of caution, an mdr will be submitted.

Event Description

The patient expired during their prescribed zio at wear period.

• 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: 17106819
• MDR Text Key: 316956467
• Report Number: 3007208829-2023-00032
• 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: 05/14/2023

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: 10/01/2023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Female