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U.S. Department of Health and Human Services

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

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NEURONETICS, INC. NEUROSTAR TMS THERAPY SYSTEM TRANSCRANIAL MAGNETIC STIMULATOR Back to Search Results
Model Number 81-00315-000
Event Date 07/01/2011
Event Type  Injury  
Event Description

Neuronetics received a call on (b)(4) 2011 that a pt being treated with neurostar tms therapy had a seizure on (b)(6) 2011. The pt is a (b)(6) woman with recurrent major depressive disorder and bipolar affective disorder. During the tms treatment session she was witnessed by the tms treater to have her hand move toward her chest, have a brief vocalization, lose consciousness, and then have full body shaking. The treater stopped the tms, activated the hospital emergency response system, and called the supervising psychiatrist, who arrived within two minutes by which time the movements had stopped. The pt was noted to have post-ictal disorientation which resolved. The pt was transported to the local emergency department for assessment. Her eval in the er was unremarkable, and she was discharged to home. The pt contacted the attending psychiatrist after her discharge from the er to report that she was doing well. The pt was on her 10th tms session of her course of tms therapy. She had tolerated the tms treatments, but during treatments had continuous right arm movement as well as intermittent nausea. Her motor threshold level was 1. 04.

 
Manufacturer Narrative

The treating psychiatrist believes this event to be device related. Neuronetics believes that assessment of relatedness is confounded by the use of fluoxetine, aripiprazole and lithium carbonate, all of which individually may have an increased risk of seizure. In addition, the pt has a family history of seizure disorder. A role for tms is not ruled out however, since seizures are known to occur with tms therapy in the presence of agents or conditions which lower a pt's seizure threshold. The fluoxetine package insert states: "in u. S. Placebo-controlled clinical trials for major depressive disorder, convulsions (or reactions described as possibly having been seizures) were reported in 0. 1% of patients treated with prozac (fluoxetine hcl) and 0. 2% of patients treated with placebo. No patients reported convulsions in u. S. Placebo-controlled clinical trials for either ocd or bulimia. In u. S. Prozac (fluoxetine hcl) clinical trials, 0. 2% of 10,782 patients reported convulsions. The percentage appears to be similar to that associated with other marketed drugs effective in the treatment of major depressive disorder. Prozac (fluoxetine hcl) should be introduced with care in patients with a history of seizures. " the aripiprazole pi notes: "in short-term, placebo-controlled trials, seizures/convulsions occurred in 0. 1% (3/2467) of adult patients treated with oral aripiprazole, in 0. 2% (1/611) of pediatric patients (6 to 17 years) and in 0. 2% (1/501) of adult aripiprazole injection-treated pts. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, e. G. , alzheimer's dementia. ".

 
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Brand NameNEUROSTAR TMS THERAPY SYSTEM
Type of DeviceTRANSCRANIAL MAGNETIC STIMULATOR
Manufacturer (Section D)
NEURONETICS, INC.
31 general warren blvd
malvern PA 19355
Manufacturer Contact
judy ways, phd
31 general warren blvd
malvern , PA 19355
6109814107
MDR Report Key2227081
Report Number3004824012-2011-00005
Device Sequence Number1
Product CodeOBP
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number81-00315-000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received07/05/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/18/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/19/2011 Patient Sequence Number: 1
Treatment
FLUOXETINE 40MG (DAILY)
ARIPIPRIZOLE 5MG (DAILY)
LITHIUM CARBONATE 900MG (DAILY)
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