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

Device Problems Device Alarm System (1012); Defective Device (2588)

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

Event Date 02/23/2018

Event Type  malfunction  

Event Description

Due to continuing issues with heart palpitations, my dr ordered a heart monitor to be worn for two weeks.The cardiologist's once affixed a zio xt patch to my chest and sent me home.During the night, the patch alarm kept going off indicating it was not working properly.I called the 800 number that accompanied the patch, and they advised me to try and re-secure the patch.However, the alarm (light) kept going off over a two day period indicating the patch was not working properly.I called the company again, and after only two days of the fourteen days, my physician wanted me to wear the monitor.I was instructed by the company to return the monitor to the mfr, irhythm technologies, (b)(4).My physician was advised about the patch not working.After months with no response, the company sends a bill for the patch less the (b)(6) payment received.However, my physician claims not receiving any data from the company as regards even the small amount of info the patch may have collected assuming, it was even accurate given the faulty device and less than 2 days of the desired 14 days of monitoring completed.I made several visits to my fp after returning the patch, and he indicated he had not received any details from the company.After my husband contacted the company on (b)(6) 2018 to discuss the co-pay, they finally contacted my physician on (b)(6) 2018 with what they claimed was sufficient data showing no cardiac issues were detected - hard to imagine that in less 2 days, they were able to determine what the physician wanted to see after 14 days of monitoring.While my palpitations were eventually controlled with medication, the possibility of a serious cardiac event occurring because the company failed to report even the insufficient amount of data to my physician immediately after they received the monitor back in (b)(6) 2018 is indeed scary.The company acted in a careless manner and it also appears there may be a technical flaw as regards the monitor itself as well as the manner in which this critical medical device is secured to the pt to provide accurate and thorough heart monitoring during the prescribed time period.

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 7846690
• MDR Text Key: 119647555
• Report Number: MW5079581
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 82