MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Nonstandard Device (1420)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Fatigue (1849); Hypoxia (1918); Dizziness (2194); Loss of consciousness (2418); Bronchial Hemorrhage (4456)

Event Date 01/01/2024

Event Type  Death  

Event Description

All family were together for new year.My mom was fine but for couple of weeks she complained about dizziness and fatigue.She reported that to her physician, but they didn't change her medications.My mom went home with my dada and she said she cannot breath and she collapsed.She [passed away on january 1st due to lung hemorrhage which led to hypoxia and cardiac arrest.She didn't have any lung problem in her whole life, her doctor started ozempic for her to weight loss and cardiac benefit.She was on xarelto too for her afib.She also had flutter and was sent home with a device that had recall on it.(b)(6).

• Brand Name: ZIO
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 18588140
• MDR Text Key: 333957141
• Report Number: MW5150745
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FUROSEMIDE ; MAGNESIUM; METOPROLOL; MULTIVITAMIN ; OZEMPIC; SOTALOL; SPIRONOLACTONE; XARELTO
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White