MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO XT PATCH; ZIO PATCH

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

The original ecg report provided to the physician included multiple syncopal pause events.On further review of the events by internal clinical experts, it was determined that the events may have been artifact signal of the ecg device.The ecg report was amended.Treatment was not administered to the patient as a result of the original report.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 500; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 500; san francisco CA 94103
• Manufacturer Contact: rich laguna ; 650 townsend street; suite 500; san francisco, CA 94103
• MDR Report Key: 7275476
• MDR Text Key: 100433108
• Report Number: 3007208829-2018-00004
• Device Sequence Number: 1
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: 00869770000203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/18/2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR