MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-29 for QUELL manufactured by Neurometrix, Inc..
[76500548]
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?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070112 |
| MDR Report Key | 6604533 |
| Date Received | 2017-05-29 |
| Date of Report | 2017-05-29 |
| Date of Event | 2017-05-12 |
| Date Added to Maude | 2017-06-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUELL |
| Generic Name | NERVE STIMULATOR |
| Product Code | NUH |
| Date Received | 2017-05-29 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMETRIX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-29 |