MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for NEUROSTAR TMS THERAPY manufactured by Neuronetics.
[60289466]
I was prescribed tms, the first unit/device i was placed under was mildly headache lasting about 2 hours. Three sessions later, i was directed to a different room with a newer version, which was a sharper, stronger electrical sensation, giving me a headache lasting all day and leaving a metallic taste in my mouth. I have only seven total sessions at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066079 |
| MDR Report Key | 6106131 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-14 |
| Date Added to Maude | 2016-11-16 |
| 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 | TMS |
| Product Code | OBP |
| Date Received | 2016-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |