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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Swelling/ Edema (4577)

Event Date 04/12/2021

Event Type  Injury  

Event Description

Subject no.(b)(6), was screened and randomized on (b)(6) 2021 for protocol cv185-749 virtually.Subject was randomized to zio xt monitor arm and the device was applied at home on (b)(6) 2021 per protocol.Subject had no known allergies to any adhesives prior to the enrollment.Subject removed the device after completing the 14 days and return the device to irhythm technologies on (b)(6) 2021.Subject skin was bruised and swollen in the area of the device patch.Fda safety report id# (b)(4).

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 11693120
• MDR Text Key: 246604564
• Report Number: MW5100857
• Device Sequence Number: 1
• Product Code: DSH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/30/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR