MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT; RECORDER, MAGNETIC TAPE, MEDICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  Death  

Manufacturer Narrative

A patient death was identified as part of a retrospective review of complaints.A timeline of events is as follows: on (b)(6) 2021, the zio® xt device was registered, activated and placed in clinic.On (b)(6) 2022 the patch was received at irhythm for processing.On (b)(6) 2022, the patient expired.On (b)(6) 2022, at the request of the account, the report was posted.In (b)(6) 2021, irhythm was experiencing a backlog of reports in the scanning queue, which caused a minor delay in posting the final report.While the report was being processed by irhythm, the patient expired.

Event Description

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

Manufacturer Narrative

Correction: b3: date of this event.B4: date of this report.B5: describe event or problem.H10: manufacturing narrative.This patient was prescribed zio xt on (b)(6) 2021 and the device was activated in the physician's office.Zio xt is a retrospective ecg monitor similar to the holter device.The zio xt patch is a prescription-only, single patient use, continuously recording ecg monitor that can be worn up to 14 days.It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.The device was returned on (b)(6) 2021 and data was downloaded for ecg analysis.Device diagnostics confirmed that the device functioned as intended with 100% leads on for a total of 13.71 days.There were no device errors or battery issues during the monitoring period.The ecg monitoring conducted as an independent diagnostic testing facility (idtf) governed by 42 cfr 410, reviewed the data and posted the final report on (b)(6) 2021.The patient expired on (b)(6) 2021.Upon review of the patient's ecg data by an irhythm cardiac rn and cardiologist, the frequency of non-sustained vt was significant but the length of runs and the rate of runs were not clinically actionable throughout the 13.7 day wear period, therefore neither the device or ecg monitoring service contributed to this patient's death.

Event Description

This mdr is being filed as the result of an update to our adverse event reporting procedure.The event occurred on 08jun2021, but due to the new criteria, the awareness date is 18nov2022.

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• 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: 15988209
• MDR Text Key: 305529757
• Report Number: 3007208829-2022-00059
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• PMA/PMN Number: K121319
• 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,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/09/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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: 67 YR
• Patient Sex: Male