MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for BRAINSWAY SREPETITIVE TRANSCRANIAL MAGNETIC TIMULATION 120 % MOTOR THRESHOLD 102B manufactured by Brainsway Ltd..
[33839283]
Participant had a generalized tonic clonic seizure during the administration of ther first rtms session at full strength (120% of mt). The seizure lasted about a minute and the participant lost consciousness, but not control of bowels. The rtms was discontinued and the participant was brought to the emergency room via ambulance. She was evaluated in the emergency room and discharged to home. Dose of amount; 20hz, frequency 55 trains and route 120% mt, 1980 pulses/session. Dates of use: phase 1 (sham) (b)(6) 2015, event stopped: doesn't apply and phase 2 (active) (b)(6) 2015; event stopped after use: yes. Major depressive disorder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058561 |
| MDR Report Key | 5306158 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-09 |
| Date Added to Maude | 2015-12-17 |
| 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 |
| 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 | BRAINSWAY SREPETITIVE TRANSCRANIAL MAGNETIC TIMULATION 120 % MOTOR THRESHOLD |
| Generic Name | BRAINSWAY DEEP TMS SYSTEM |
| Product Code | OBP |
| Date Received | 2015-12-14 |
| Model Number | 102B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD. |
| Manufacturer Address | 19 HARTUM ST. BYNET BLDG., 3RD FL. HAR HOTZVIM, JERUSALEM 9777518 IS 9777518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-14 |