MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-23 for NEUROSTAR TMS THERAPY DEVICE 81-60000-000 manufactured by Neuronetics, Inc..
[68102909]
The treating physician assesses the event as treatment emergent mania (tem) which is definitely related to the patient's tms treatment, with the tem leading to the patient's subsequent hospitalization. Neuronetics believes the event of tem is probably tms related. Although tem has been reported for patients with unipolar and bipolar depression after tms stimulation of the left prefrontal cortex, the overall rate of tem is low, with equal rates seen between both active and sham groups, and below the natural switch rates in patients with bipolar disorders receiving mood stabilizers. (with g, et al. Treatment-emergent mania in unipolar and bipolar depression: focus on repetitive transcranial magnetic stimulation. Int j neuropsychopharmacol. 2008 feb; 11 (1): 119-30. ). No known device problem.
Patient Sequence No: 1, Text Type: N, H10
[68102910]
The patient is a (b)(6) y/o woman with long standing bipolar disorder, type ii, predominantly depression with occasional mixed mania. The patient began tms treatment for her bipolar disorder on (b)(6) 2016. Neurostar tms is not indicated for the treatment of bipolar disorder. Over the course of her tms treatment, her quick inventory of depressive symptomatology score decreased for 26 to 16, while her young mania rating scale score increased from 4 to 20. On (b)(6) 2016, when the patient arrived for her 25th tms treatment, she had acutely decompensated with symptoms of agitation, insomnia and racing thoughts. She expressed suicidal ideation to the treating physician, so the patient was hospitaized. The patient was discharged in stable condition after a 10 day hospitalization during which time her latuda dose was increased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004824012-2017-00001 |
| MDR Report Key | 6352363 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-23 |
| Date of Report | 2017-01-31 |
| Date of Event | 2016-12-22 |
| Date Mfgr Received | 2017-01-03 |
| Device Manufacturer Date | 2013-02-05 |
| Date Added to Maude | 2017-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR JUDY WAYS |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6109814107 |
| Manufacturer G1 | NEURONETICS, INC. |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS THERAPY DEVICE |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION |
| Product Code | OBP |
| Date Received | 2017-02-23 |
| Model Number | 81-60000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Manufacturer Address | 3222 PHOENIXVILLE PIKE MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-02-23 |