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U.S. Department of Health and Human Services

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

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NEUROMETRIX, INC. QUELL NERVE STIMULATOR Back to Search Results
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?.
 
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Brand NameQUELL
Type of DeviceNERVE STIMULATOR
Manufacturer (Section D)
NEUROMETRIX, INC.
MDR Report Key6604533
MDR Text Key76500548
Report NumberMW5070112
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
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 Received05/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2017 Patient Sequence Number: 1
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