MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for NEUROSTAR TMS THERAPY SYSTEM manufactured by Neuronetics, Inc..
[63824823]
Transcranial magnetic stimulation. It made my depressions so much worse. I can no longer function like i used to before. It has also caused severe activation which has caused me to have terrible insomnia which lead to pain all over my body and weakness. I can hardly walk or move my body. I had to go onto some serious sleep meds and other meds because of this. Now it's 11 months later and i'm still in pain and suffering. Ref report numbers mw5072838 and mw5074918.
Patient Sequence No: 1, Text Type: D, B5
[81031034]
Additional info received from reporter on 07/05/2017 for mw5067012: the patient states that the machine was supposed to treat depression, but instead it caused more pain and made the depression worse. Patient states that he believes the device does harm and should be banned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067012 |
| MDR Report Key | 6217919 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-29 |
| Date of Event | 2016-01-01 |
| Date Added to Maude | 2017-01-03 |
| 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 | NEUROSTAR TMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2016-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-12-29 |