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

Device Problems Failure To Adhere Or Bond (1031); Failure to Sense (1559)

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

Event Date 03/13/2018

Event Type  malfunction  

Event Description

Design issue with zioxt heart monitor.On 5th day, toward end of day, took off light weight merino sweater and noticed blinking orange light.Called mfr to help line and was told the light signified the leads may not be firmly attached against chest and that monitor may not be registering.For now pressing down on both leads resulted in "restoration of unit".However because the "lead detachment" was silent, i have no idea as to how long the leads were not properly affixed to my chest.It wasn't as if i was exercising or performing strenuous feats - i was at my desk for several hours.Who knows how long the monitor may not have been capturing data, especially during the times i activated the monitor when i felt a change in rhythm.Now i will need to check way more frequently during the day and at night, especially as the wireless patch is subjected to more daily wear and tear.

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE MEDICAL
• Manufacturer (Section D): IRHYTHM
• MDR Report Key: 7344556
• MDR Text Key: 102847182
• Report Number: MW5075884
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/18/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 79