MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-24 for NEUROSTAR TMS THERAPY SYSTEM manufactured by Neuronetics.
[34702492]
Starting from (b)(6) 2015 i underwent treatment for depression using repetitive transcranial magnetic stimulation (rtms) for one hour, five days a week, for six weeks. This was using the neurostar machine. After six weeks my treatment was stopped but my depression did not lessen. A few days after treatment was stopped, i noticed that the tinnitus that i had in my left ear since 2008 was much louder and higher in frequency than before. I also developed hyperacusis and also started noticing tinnitus in my right ear as well. Before my tinnitus was rather mild, but now it was so loud and high pitched that i could hear it over everything. It became difficult to sleep and i even became suicidal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058804 |
| MDR Report Key | 5335596 |
| Date Received | 2015-12-24 |
| Date of Report | 2015-12-24 |
| Date of Event | 2015-08-31 |
| Date Added to Maude | 2015-12-30 |
| 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 | 3 |
| Brand Name | NEUROSTAR TMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION SYSTEM |
| Product Code | OBP |
| Date Received | 2015-12-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-24 |