MAUDE Adverse Event Report: IRHYTHM ZIO HEART MONITOR

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); Electric Shock (2554)

Event Date 11/23/2017

Event Type  Injury  

Event Description

I was wearing a zio heart monitor prescribed by my doctor.After awakening with dizziness and walking to the bathroom, i experienced what felt like an explosion in my chest.My upper body lurched upward and forward and my arms flew up in the air.It felt like i had been shocked.I would like to know what research was done regarding the zio heart monitor being worn by mastectomy pts with silicone implants.

• Brand Name: ZIO HEART MONITOR
• Type of Device: ZIO HEART MONITOR
• Manufacturer (Section D): IRHYTHM
• MDR Report Key: 7159791
• MDR Text Key: 96368299
• Report Number: MW5074343
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 82