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

Model Number 81-60000-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Depression (2361)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: NEUROSTAR TMS THERAPY DEVICE
• 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: 6352363
• MDR Text Key: 68102909
• Report Number: 3004824012-2017-00001
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-60000-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2013
• 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: CONCERTA; KLONOPIN; LEVOTHYROXINE; LITHIUM; LURASIDONE (LATUDA); PREMARIN; PROZAC; TRAZODONE; VITAMIN B12; VITAMIN D3
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR