MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-26 for NEUROSTAR TMS THERAPY SYSTEM 81-61000-000 manufactured by Neuronetics, Inc..
[5829748]
The treating physician contacted neuronetics on (b)(6) 2015 to report the (b)(6) 2015 hospitalization of a patient for suicidal ideation. The patient is a (b)(6) y/o woman with life-long recurrent major depression (mdd). Her baseline symptom scores were phq9-22, madrs-27. Her first tms treatment was on (b)(6) 2014. She did well during her first two weeks of tms therapy with improvement in her symptom scores and increased energy, but also had racing thoughts. The following week, she began to have symptom worsening, crying, and expressed that she did not want to continue living. She continued tms treatment, but by (b)(6) 2014, her symptom scores were phq9-19 and madrs-21. On (b)(6) 2015, the patient expressed a plan to kill herself with a gun available in her house, so her physician had her hospitalized. She was discharged on (b)(6) 2015, no longer suicidal; her pristiq and lithium were discontinued and substituted with viibryd 40mg/d.
Patient Sequence No: 1, Text Type: D, B5
[13419045]
The treating physician believes this event is device related. Neuronetics believes that the patient's suicidal ideation and subsequent hospitalization is probably not device related but rather consistent with her current depressive episode. The factors favoring this event being consistent with her current depressive episode include a prior history of suicidal ideation, a history of ineffective response to treatment with pharmacotherapy in this and prior depressive episodes, the patient's report on admission to the hospital that her current depressive episode had begun in (b)(6) 2014 and the patient's report that she had not responded to medications or her 31 tms treatment sessions. The neurostar tms therapy system labeling informs that patients who have major depressive disorder may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior and that patients should be observed closely for worsening symptoms and signs of suicidal behavior and/or unusual behavior. If worsening of symptoms continues,consideration should be given to changing the therapeutic regimen, including discontinuation of treatment with the neurostar tms therapy. The device history records and service records were reviewed and it was confirmed that there were no device malfunctions and the device was functioning as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2015-00001 |
| MDR Report Key | 4797234 |
| Report Source | 05 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-26 |
| Date of Event | 2015-01-02 |
| Date Mfgr Received | 2015-04-26 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2015-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION |
| Product Code | OBP |
| Date Received | 2015-05-26 |
| Model Number | 81-61000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-05-26 |