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

Device Problem Data Problem (3196)

Patient Problem Arrhythmia (1721)

Event Date 08/05/2022

Event Type  Death  

Manufacturer Narrative

The patient expired on (b)(6) 2022, after approximately 2.12 days of the prescribed 14-day wear-period.Episodes of complete heart block (chb), ventricular asystole due to chb, and torsades occurred on (b)(6) 2022 at 12:46 pm during the wear-period; these episodes were not communicated to the account, as they were not transmitted to irhythm servers.The timeline of events is as follows: the patient experienced light-headedness, sought medical attention and was admitted to the hospital on (b)(6) 2022.The patient had a transcatheter aortic valve replacement procedure on (b)(6) 2022.Following the surgical procedure, a zio at device was placed on the patient and she was discharged on (b)(6) 2022.The last transmission from the device to irhythm servers was received the same day of the discharge, on (b)(6) 2022.The patient passed some time between the eol events which began on (b)(6) 2022 and (b)(6) 2022, when the patient was found deceased.On (b)(6) 2022 an incomplete device was received at irhythm.A review of the available device diagnostic confirmed there were no device issues with the patch (returned portion).Without the missing portion of the device a conclusive investigation cannot be completed, as a failure of the gateway cannot currently be ruled out, therefore an mdr will be submitted.

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: 15601826
• MDR Text Key: 301712206
• Report Number: 3007208829-2022-00049
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

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: 10/29/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Female