MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-04 for EEG TREATMENT (FLEXYX NEUROTHERAPY SYSTEM) UNK manufactured by Neurotherapy Center Of Washington, Inc..
[492968]
After eeg treatements, became very anxious, agitatted, increased heart rate, difficulty breathing, with frequent and intrusive suicidal thoughts and ideation, psychodelic-rapid visuals when trying to fall asleep. Ended up in emergency room because i was having significant trouble breathing, rapid heart rate, etc. Stopped treatment nearly one month ago and continue to have significant symptoms including thoughts, rapid thinking, racing thoughts, psychodelic visuals when eyes are closed, difficulty falling asleep. I've reread the consent form which states no one had had significant side effects from this treatment. Dr gave eeg treatment using multiple operators of medical device - 4 different practitioners of device (there is nothing stating this in her treatment form. In addition, the consent form states that "no one" has had severe or signicant side effects from eeg treatment - certainly not suicide thinking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1039026 |
| MDR Report Key | 722529 |
| Date Received | 2006-05-04 |
| Date of Report | 2006-04-28 |
| Date of Event | 2006-03-06 |
| Date Added to Maude | 2006-06-07 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EEG TREATMENT (FLEXYX NEUROTHERAPY SYSTEM) |
| Generic Name | EEG TREATMENT ELECTRICITY DIRECTED INTO HEAD |
| Product Code | HCC |
| Date Received | 2006-05-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 711597 |
| Manufacturer | NEUROTHERAPY CENTER OF WASHINGTON, INC. |
| Manufacturer Address | 5480 WISCONSIN AVE STE 221 CHEVY CHASE MD 20815 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2006-05-04 |