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

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint revealed that the patient wore the xt for 1 of the 14 days prescribed.The patient has no history of reactions to medical adhesive or sensitive skin.The exact cause of the reported event cannot be determined.However, skin irritation is a known inherent risk of the device.The device manual warnings section read as follows: do not use the zio xt patch on patients with known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies.Patient may experience skin irritation.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient¿s chest.This event is being reported per 21cfr803 as a serious injury.This report does not constitute an admission by rhythm that the product described in this report has any defects or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.
Event or Problem Description
The patient presented to their healthcare provider with skin irritation and signs of a secondary infection, allegedly caused by the zio xt.The patient reported experiencing itching and redness at the zio xt site.The device was removed, and the patient was prescribed topical ointment as part of post-care.
Additional Manufacturer Narrative
This supplemental report is being submitted in response to the fda notification received on september 26, 2024, concerning missing udi numbers in mdr submissions from october 2023 through december 2024.In response to this issue, irhythm conducted an investigation and identified a system processing error, which has now been resolved.Please see the update in section d4.

• Brand Name: ZIO XT
• Common Device Name: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA 90630
• Manufacturer Contact: tara mackinnon ; 699 8th st suite 600; san francisco, CA 94103 ; 6094600577
• MDR Report Key: 20892750
• Report Number: 3007208829-2024-00490
• Device Sequence Number: 15396733
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: (01)00869770000203(17)250323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/23/2025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male