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 Arrhythmia (1721)

Event Date 10/18/2021

Event Type  Death  

Manufacturer Narrative

This mdr is being filed due to a retrospective review of complaints per new established criteria for adverse event reporting.The awareness date represents the date this complaint was identified as meeting the new criteria.A follow-up mdr will be submitted should new significant information be obtained relative to this event.Below is a timeline of events supported by data obtained from the subject device: on b)(6) 2021, a zio® at home enrollment device was shipped to the patient.An inbound call from the patient¿s caregiver was received on b)(6) 2021 who stated the patient was taken to the hospital.It is unknown for what reason the patient went to the hospital or if the patient was admitted.On b)(6) 2021, the device reached its limit of 500 transmissions.The account was notified the device had reached the asymptomatic transmission limit on b)(6) 2021 and a replacement device was dispatched to the patient overnight.Multiple attempts were made to contact the patient and the account to notify that the patients replacement device was not active or transmitting, and on (b)(6) 2022 the patient expired while wearing the initial device.Both devices were returned to irhythm; the replacement device was received unopened as the device was never worn by the patient.Investigation into the reported issue has confirmed that the worn device did not malfunction.Each device will transmit up to 500 asymptomatic cardiac events.This constraint is necessary to preserve battery life for the full intended wear-period.Patient-triggered symptomatic transmissions are still able to be transmitted beyond this limit by pressing the large central button located on the outer device housing.This does not constitute a malfunction of the device as the device is functioning as designed.

Event Description

The patient suffered a fatal cardiac event during mobile cardiac telemetry monitoring.

• 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: 15912222
• MDR Text Key: 304772569
• Report Number: 3007208829-2022-00055
• 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: 11/18/2022

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: 03/15/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• 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: 69 YR
• Patient Sex: Male