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 Problem Skin Infection (4544)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

Skin irritation is a known inherent risk of the device.Nlb0061 (xt he) warnings state the following: do not use the zio monitor on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the patch from the patient¿s chest.Per clinical reference manual (nlb0020 ¿xt us) a critical step to achieve good signal quality and adhesion is to ensure the skin is prepared by shaving, abrading and cleaning with alcohol pads.This step may contribute to skin irritation and/ or itching while wearing the device.

Event Description

The patient presented to their healthcare provider with a skin injury.The patient reported signs of secondary infection to the injury.Antibiotics were prescribed by the patient's healthcare provider.

• Brand Name: ZIO XT
• Type of Device: 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: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15821580
• MDR Text Key: 303898291
• Report Number: 3007208829-2022-00052
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/07/2023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male