MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for NEUROSTAR manufactured by Neuronetics, Inc..
[114501914]
As a possible side effect of the therapy, i developed anxiety mid way through the therapy (around (b)(6)). I continually told the tms dr and the tms tech. It progressively worsened. When i was done with the tms, the anxiety continued to get worse and i developed severe insomnia. I was put on zoloft for the anxiety, which helped during the day. Numerous sleeping meds were attempted, only 1 of them worked for several weeks, but then stopped working. I have been to the er 3 times; the first time, after not sleeping for 4 nights, i got a shot and slept for 13 hrs. The second time, i passed out, felt on my face and was sent to the er. The third time, i was again sleep deprived after 4 nights of only sleeping 2 hrs: a new sleeping pill was prescribed which didn't help. I saw my psychiatrist the next day and was prescribed remeron for my depression (which was significantly worsened due to the anxiety), which helped to get 6 hrs of sleep. I am now having to go through a 3 week outpatient hospitalization program to deal with the anxiety and insomnia issues.
Patient Sequence No: 1, Text Type: D, B5
[115244129]
Add'l info received from reporter on 07/25/2018 for mw5078458: the pt stated that she underwent 36 treatments of transcranial magnetic stimulations, over the time period of (b)(6) to (b)(6) for depression. The pt states that she has never had anxiety before, nor was it explained to her as a possible side effect of the therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078458 |
| MDR Report Key | 7697734 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-04-27 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| 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 | NEUROSTAR |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2018-07-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2018-07-17 |