MAUDE Adverse Event Report: NEUROMETRIX, INC. QUELL; NERVE STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/12/2017

Event Type  Injury  

Event Description

I purchased a quell device and tried it for 2 days.I have fibromyalgia and was looking for a non-drug solution to the pain.After two days of use, i went into a-fib twice over a three day period, the longest event lasting over 14 hours.After multiple communications with the company help desk, they finally admitted that a-fib is a potential result from using the device.I have been unable to find any proactive warnings that this is a potential.How many of their customers have ended up going into afib? or worse, how many go into a-fib and don't realize it because they are not checking?.

• Brand Name: QUELL
• Type of Device: NERVE STIMULATOR
• Manufacturer (Section D): NEUROMETRIX, INC.
• MDR Report Key: 6604533
• MDR Text Key: 76500548
• Report Number: MW5070112
• Device Sequence Number: 1
• Product Code: NUH
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2017
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 113