MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for BRAINSWAY DEEP TMS SYSTEM (H1 COIL) HEL-260215004-3 manufactured by Brainsway Ltd.
[121991501]
The patient was as (b)(6) married white female with a 20+ year history of depression and anxiety, previously tried on multiple antidepressants. She was receiving tms for the treatment of resistant depression using the brainsway hi coli. During treatment #11, she experienced a generalized seizure, including tongue biting with bleeding, vomiting, and post-ictal confusion. She was taken to the emergency room (er) for evaluation and the released. The patient wanted to continue treatment (b)(6) 2018, we started the brainsway treatment again. The patient was unable to complete a full course of tms despite having a seizure with no additional complications, no changes to the eeg, and with clinical improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080096 |
| MDR Report Key | 7909977 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-04-23 |
| Date Added to Maude | 2018-09-26 |
| 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 DEEP TMS SYSTEM (H1 COIL) |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2018-09-25 |
| Model Number | HEL-260215004-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD |
| Manufacturer Address | JERUSALEM 91451 IS 91451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-09-25 |