MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR TMS THERAPY SYSTEM; TRANSCRANIAL MAGNETIC STIMULATION

Model Number 81-61000-000

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Anxiety (2328); Depression (2361)

Event Date 01/02/2015

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: NEUROSTAR TMS THERAPY SYSTEM
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: judy ways ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814107
• MDR Report Key: 4797234
• MDR Text Key: 5829748
• Report Number: 3004824012-2015-00001
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 81-61000-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISTIQ (DESVENLAFAXINE) 50MG QD; LITHIUM CARBONATE 300MG BID
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR