MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for NEUROFEEDBACK EEG manufactured by Unk.
[128206918]
Reporter stated that she went for treatment for chronic insomnia where a neurofeedback therapy was initiated. This procedure was done at (b)(6). Reporter experienced a heart rate of 121 bpm and had to go to the emergency room. Reporter has been through two episodes of this sort. Reporter is currently at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081548 |
| MDR Report Key | 8095264 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-11-17 |
| Date Added to Maude | 2018-11-21 |
| 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 | NEUROFEEDBACK EEG |
| Generic Name | DEVICE, BIOFEEDBACK |
| Product Code | HCC |
| Date Received | 2018-11-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |