MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-24 for NEUROSTAR TMS THERAPY manufactured by Neuronetics Inc..
[48524638]
Did transcranial magnetic stimulation. This is a new procedure that uses magnetic pulses on the brain to help depression. Supposed to do 30 session 5 days a week for about 45 minutes. All the research says the only side effects are mild scalp irritation and headache where the magnetic touch the head. After a few days of doing it, i felt sick, nausea, and my depression became extremely worse. I questioned the doctor who said this doesn't happen, never heard of depression getting worse. We kept going and by the 20th session i was so sick and depressed. I had to stop. Plus it became so activated, i could not sleep. I was on no medications prior to doing this. I had to get an emergency visit to a psychiatrist who put me on antidepressants to this day aren't helping. I can no longer take a med. The depression is too severe causing me to hardly be able to move my body. I have chronic pain all over my body. I can no longer do things i used to be able to do. This procedure ruined my life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063149 |
| MDR Report Key | 5758226 |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-06-17 |
| Date Added to Maude | 2016-06-29 |
| 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 | NEUROSTAR TMS THERAPY |
| Generic Name | NEUROSTAR TMS THERAPY |
| Product Code | OBP |
| Date Received | 2016-06-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-06-24 |