MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for TMS MACHINE manufactured by Unk.
[96224823]
My tms tech incorrectly performed transcranial magnetic stimulation on me and caused me to have the first seizure of my life. He raised the intensity of the machine so high that it caused full body convulsions and intense jaw clenching. Tms therapy to my knowledge has only been cleared by the fda to be performed on the left side of the head. My tech said he did it bilaterally, and towards the right side of my head. When i asked him how he got insurance to cover it, he said "i just don't tell them i treat both sides. " i feel as though he is a danger to pts and should not be allowed to product this procedure at all. I now suffer from several health issues that i did not have before. In addition, he is knowingly committing insurance fraud by billing my insurance for a procedure that's not supposed to be done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074332 |
| MDR Report Key | 7157005 |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-10-02 |
| Date Added to Maude | 2018-01-02 |
| 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 | TMS MACHINE |
| Generic Name | TRANSCRANIAL, MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2017-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | TMS MACHINE |
| Generic Name | TRANSCRANIAL, MAGNETIC STIMULATOR |
| Product Code | GWF |
| Date Received | 2017-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-12-29 |