MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for BRAINSWAY DEEP TMS MACHINE manufactured by Brainsway Ltd..
[137984496]
I received transcranial magnetic stimulation on (b)(6). I immediately had shoulder pain after treatment. The pain was in my opposite shoulder of treatment (left), where twitching and pulling occurs of the muscles. I was putting pain ointment on the area the morning of (b)(6), and realized my left arm was very swollen and red. I went to urgent care where i was diagnosed with a deep vein thrombosis (dvt-blood clot) in the axillary vein of my left arm. A week later i was still having pain and had a pulmonary embolism in the chest area of where the muscle twitching occurs. I am on a high strength of the machine because i am currently taking 50 mg of trokendi. I think there needs to be a warning on the machine to limit the strength of the machine as this is dangerous.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084658 |
| MDR Report Key | 8392423 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-12 |
| Date Added to Maude | 2019-03-05 |
| 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 | 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 | BRAINSWAY DEEP TMS MACHINE |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2019-03-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2019-03-05 |