MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-08-19 for NEUROSTAR TMS THERAPY SYSTEM 81-00315-000 manufactured by Neuronetics, Inc..
[2242112]
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.
Patient Sequence No: 1, Text Type: D, B5
[9402514]
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. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2011-00005 |
| MDR Report Key | 2227081 |
| Report Source | 00 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-07-01 |
| Date Mfgr Received | 2011-07-05 |
| Device Manufacturer Date | 2009-09-18 |
| Date Added to Maude | 2011-09-02 |
| 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, PHD |
| Manufacturer Street | 31 GENERAL WARREN BLVD |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6109814107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2011-08-19 |
| Model Number | 81-00315-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Manufacturer Address | 31 GENERAL WARREN BLVD MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-19 |