MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for NEUROSTAR TMS manufactured by Neuronetics Inc..
[177547167]
Seizure - fell to floor; i was receiving transcranial magnetic stimulation (tms) to treat depression at (b)(6) health under dr (b)(6). The (b)(6) attendant, (b)(6), left before the first cycle. When i realized that there was something wrong (that the tms helmet was not on correctly), i screamed in extreme pain for help, as my arm moved uncontrollably, feeling like it was ripping off. I then lost consciousness. But no one came in response to my screaming or my collapse. After the procedure was scheduled to be over, (b)(6) returned to the room and found me on the floor. He called for ems. This happened once before and the tech readjusted the helmet and my arm stopped moving. Showed broken down muscle indicate of a seizure. Also evidence i had bit my tongue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092669 |
| MDR Report Key | 9653836 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-02-02 |
| Date Added to Maude | 2020-01-31 |
| 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 | 3 |
| Brand Name | NEUROSTAR TMS |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2020-01-30 |
| 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. Life Threatening; 2. Other | 2020-01-30 |