Brand Name | NEUROSTAR ADVANCED THERAPY |
Type of Device | TRANSCRANIAL MAGNETIC STIMULATOR |
Manufacturer (Section D) |
NEURONETICS, INC. |
3222 phoenixville pike |
malvern PA 19355 |
|
Manufacturer (Section G) |
NEURONETICS, INC. |
3222 phoenixville pike |
|
malvern PA 19355 |
|
Manufacturer Contact |
anna
gorbunov
|
3222 phoenixville pike |
malvern, PA 19355
|
6106404202
|
|
MDR Report Key | 18187409 |
MDR Text Key | 328742760 |
Report Number | 3004824012-2023-00026 |
Device Sequence Number | 1 |
Product Code |
OBP
|
UDI-Device Identifier | 00850005944522 |
UDI-Public | 00850005944522 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K230029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/27/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/21/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Model Number | NEUROSTAR ADVANCED THERAPY V3.7 |
Device Catalogue Number | 81-04335-000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/30/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | BUSPAR 15 MG THREE TIMES A DAY; LAMICTAL 200 MG DAILY; PRISTIQ 100 MG DAILY; REMERON 15 MG AT BEDTIME; TRAZODONE 50 MG AT BEDTIME |
Patient Outcome(s) |
Other;
|
Patient Age | 57 YR |
Patient Sex | Female |
Patient Race | White |