MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for BRAINSWAY TMS STIMULATOR AND H1 COIL P-N012BWS-NC1472 manufactured by Brainsway Ltd..
[177132448]
Tms pt had a seizure at 12:26 pm during treatment using the brainsway device h1 coil for mdd, dtms protocol at 18hz, 120% of rmt. Lasted approx 30 seconds, pt had no history of seizures or seizures disorder, no neurological condition and no risk factors or changes to medication, sleep, alcohol, caffeine, illicit substances prior to tx. Pt in good health. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092603 |
| MDR Report Key | 9641942 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-23 |
| Date Added to Maude | 2020-01-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BRAINSWAY TMS STIMULATOR AND H1 COIL |
| Generic Name | TRANSCRENIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2020-01-28 |
| Model Number | P-N012BWS-NC1472 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD. |
| Manufacturer Address | UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-01-28 |