MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for NEUROSTAR TMS THERAPY DEVICE manufactured by Neuronetics, Inc..
[140200794]
I went in to get tms from neurostar to treat depression, with no existing anxiety. After completing the first session, my thoughts were racing, i was screaming and banging my head against the wall. I told this to the psychiatrist and he switched the protocol from the left to right side. My depression and anxiety continued to get worse after this. I was told that what i was feeling was not possible and that i should continue as things would get better. After about thirteen sessions i ended up in the psychiatric ward. Two months later and i have debilitating anxiety, extreme heart palpitations, facial pinching and numbness, headaches, dizziness, and nausea. I was told it was impossible that symptoms would worsen, and i am at the point where i am going to kill myself because i have been totally destroyed by this treatment. I? M (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085292 |
| MDR Report Key | 8460519 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-12 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | NEUROSTAR TMS THERAPY DEVICE |
| Generic Name | TRANCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2019-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Deathisabilit | 2019-03-28 |