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

Device Problem Defective Device (2588)

Patient Problems Arrhythmia (1721); Tachycardia (2095); Loss of consciousness (2418)

Event Date 04/20/2022

Event Type  Injury  

Event Description

Patient wearing a zio patch (irhythm) at device and had 32 minutes of sustained ventricular tachycardia with loss of consciousness.Device designed to report daily events remotely and failed to report this life-threatening arrhythmia until 1 week later due to arbitrary 500 event limit.Fda safety report id# (b)(4).

• Brand Name: ZIO PATCH (IRHYTHM)
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 14345761
• MDR Text Key: 291376008
• Report Number: MW5109605
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White