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

Device Problem Use of Device Problem (1670)

Patient Problem Stroke/CVA (1770)

Event Date 11/07/2023

Event Type  Injury  

Manufacturer Narrative

The at device has not yet returned to irhythm.However, the patient¿s family contacted irhythm and was assisted with activating the gateway.No further information was provided.This event is being reported per 21 cfr 803 as a serious injury.This report does not constitute an admission by rhythm that the product described in this report has any defects, or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.

Event Description

The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The investigation revealed that the patient or the account did not activate the gateway.Once the gateway was activated, the patient¿s arrhythmia was transmitted.The healthcare provider (hcp) was immediately notified regarding the patient's arrhythmia.A follow-up call from the patient¿s family informed irhythm that the patient had been hospitalized due to a stroke.No further information was provided, such as treatment or discharge plans.

• 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; CA
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 18297695
• MDR Text Key: 330111340
• Report Number: 3007208829-2023-00194
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/26/2024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female