MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for NEUROSTAR RAPID TRANSCRANIAL MAGNETIC STIMULATION DEVICE manufactured by Neuronetics Inc..
[126495543]
Caller started using the neurostar rapid transcranial magnetic stimulation device in (b)(6) 2018, he had third-two treatment on this device; the last treatment was on (b)(6) 2018. He did not see any beneficial result instead he had headache, elevated anxiety and more depressed. He feels like he was left on the baseline of anxiety disorder. Caller stated that the therapeutic result is ineffective and the results is inadequate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081060 |
| MDR Report Key | 8042005 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-09-24 |
| Date Added to Maude | 2018-11-06 |
| 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 RAPID TRANSCRANIAL MAGNETIC STIMULATION DEVICE |
| Generic Name | NEUROSTAR TMS |
| Product Code | OBP |
| Date Received | 2018-11-05 |
| Device Availability | * |
| 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. Required No Informationntervention | 2018-11-05 |