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U.S. Department of Health and Human Services

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

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IRHYTHM TECHNOLOGIES, INC. ZIO XT PATCH RECORDER, MAGNETIC TAPE, MEDICAL Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2020
Event Type  Malfunction  
Event Description

I wore the zio xt patch device for 3 days at the direction of my cardiologist from (b)(6) 2020. On the second day, the patch came loose causing me to have to press firmly on the patch every hour to keep it on. The third day was even worse. I had followed the directions and did not expose it to water of any kind. The patch did not want to stay attached to my skin. I removed the patch as directed after the prescribed time period and mailed it off (b)(6). My cardiologist received the report and apparently the patch being loose did not affect the readings as i was cleared. A few months later, i received an eob with a charge of (b)(6) just for the report generated by this company for their own device. My insurance paid (b)(6) of it and i was billed by irhythm for (b)(6). I find this cost to be very exuberant for just a simple digital report for their own device. I wore this device at the direction of my cardiologist and it was installed in the office on the day of my visit. I was not given any other options for other monitors to wear. I also see the (b)(6) for the (b)(6) area has rated this company with an f rating. I see numerous complaints for the same issue i experienced as well as the billing issue with zero response from this company. I see great benefit in the fda looking into the operations of this product and this company. I would ask the fda look into both the attachment issue with this device as well as if the extreme cost to patients for this report is justified. I would appreciate a response on both issues. Thank you. This product has a defective adhesive and needs attention. The exuberant billing practices of this company also needs investigation. As indicated by numerous complaints on the (b)(6) website for this company, they are not responsive to these issues for anyone else. Perhaps your investigation can create some responsiveness patients are not receiving. Fda safety report id# (b)(4).

 
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Brand NameZIO XT PATCH
Type of DeviceRECORDER, MAGNETIC TAPE, MEDICAL
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC.
MDR Report Key10894224
MDR Text Key218506260
Report NumberMW5098037
Device Sequence Number1
Product Code DSH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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