MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for NEUROSTAR 81-02315-000 manufactured by Neuronetics Inc..
[146400891]
I had transcranial magnetic stimulation treatment (tms neurostar) for depression. It did not help with the depression (which was moderate) but caused debilitating anxiety that caused me to be almost non-functional and i was hospitalized. I had 36 tms treatments (all to left side of head), about half way through i descended into a severe depression, but that only lasted a few days, and i was advised to continue the treatment. The treatment was administered by a nonprofessional medical office mgr and even the supervising psychiatrist didn't seem to have much knowledge about the potential negative side effects of tms. Outcome attributed to adverse event: suicidal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086963 |
| MDR Report Key | 8650831 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-05 |
| Date Added to Maude | 2019-05-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2019-05-29 |
| Model Number | 81-02315-000 |
| 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 | 2019-05-29 |