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 Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/11/2021

Event Type  Injury  

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.The investigation revealed the device functioned as intended upon activation.A baseline transmission was received, and a daily report generated for the account.On 12/12/2021 irtc received a notice that the device had not been connected for the past 24 hours.Upon contacting the account on 12/13/2021, we learned the patient expired on (b)(6) 2021.The at patch was never returned; therefore, no further investigation could be completed.There is no indication the device had any factor or contribution to the patient¿s death as the primary indication was cerebral ischemia; but out of an abundance of caution, it will be submitted as an mdr.

Event Description

It was reported that the patient expired while prescribed the zio at mobile cardiac telemetry.

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.The investigation revealed the device functioned as intended upon activation.A baseline transmission was received, and a daily report generated for the account.On (b)(6) 2021 irtc received a notice that the device had not been connected for the past 24 hours.Upon contacting the account on (b)(6) 2021, we learned the patient expired on (b)(6) 2021.The at patch was never returned; therefore, no further investigation could be completed.There is no indication the device had any factor or contribution to the patient¿s death as the primary indication was cerebral ischemia; but out of an abundance of caution, it will be submitted as an mdr.

• 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: 16005592
• MDR Text Key: 305718832
• Report Number: 3007208829-2022-00060
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/08/2021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Female