Patient is a (b)(6) woman with recurrent depression with ideas of reference requiring recent hospitalization. She has a generalized seizure disorder, with her last seizure occurring in 2010. She was receiving tms therapy for her depression. Approximately 19 minutes into her 64th tms session, she was noted to have generalized tonic-clonic seizure with loss of consciousness, lasting less than 3. 5 minutes, followed by approximately one hour of post-ictal disorientation. After recovering from her seizure, she was able to go home. The treatment protocol, 4 seconds of 10 pulse per second trains at 140% of motor threshold with a 26 second intertrain interval (total 2500 pulses) varied from the neurotics labeled treatment protocol, and exceeds the stimulation parameters recommended in treatment guidelines for safe use of tims (wasserman, 1998). Two days prior to the event, she self-discontinued her clonazepam without informing the tims treatment staff. The treating physician assessed the event as not device related, but rather caused by clonazepam withdrawal.

(b)(4) - the treating physician believes this event is not device related. Neuronetics believes that assessment of relatedness is confounded by the patient's history of a generalized seizure disorder, and the acute discontinuation of clonazepam. 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 patient's seizure threshold including medications, a history of seizure, and the use of treatment parameters which exceed the guidelines for safe use of tms. These conditions related to the seizure are described in the neurostar tms therapy system user manual, 'warnings: risk of seizure' wassermann, e. M. (1998). Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the international workshop on the safety of repetitive transcranial magnetic stimulation, 06/07/1996. Electroencephalography and clinical neurophysiology, 108(1), 1-16.

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The pt is a (b)(6) man with mdd who had been receiving tms over the l-dlpc with stimulation parameters noted below. He noticed left eye floaters suddenly on (b)(6), just after tms session #26 on the left side. He saw an ophthalmologist on (b)(6). The ophthalmology exam revealed a new posterior vitreous detachment (pvd) on the left and an old vitreous detachment on the right. There was no retinal holes or tears. The ophthalmologist impression was that the pvd was unrelated to the tms. The pt had a single tms session on the right dorsolateral pfc on (b)(6). The ophthalmologist cleared pt to resume left-sided tms on (b)(6). After the 1st ophthalmologist visit, the tms treating physician specifically looked for eye movements or lid twitching during the tms treatments and asked the pt if he noted any visual change during the treatment session but neither he nor pt noted any movements. A second wave of acute floaters developed on (b)(6), after tms session # 35. He saw the ophthalmologist that afternoon who identified a new left retinal detachment which responded to laser treatment. The laser treatment has been holding well since (b)(6). The pt has made a good recovery of his visual function.

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Treatment parameters - motor threshold: 0. 85. Treatment protocol: dlpfc at 20hz, 80% mt, 2 sec/28 sec x 1000 pulses followed by left dlfpc 20 hz at 119% mt, 2 sec on, 28 sec off, for 2400 pulses. These parameters differ from the treatment parameters specified in the neurostar tms therapy system user manual (10hz, 120%mt, 4 sec on/26 sec off, 300 pulses). After the initial visit to the ophthalmologist the treating physician and the ophthalmologist assessed the posterior vitreous detachment (pvd) as not tms related, but after the second ophthalmologist visit for the retinal tear, they assessed the retinal tear as tms related. The neuronetics assessment of the causality is that the pvd was not tms related, with risk factors of treated hypertension, diabetes, and evidence of prior pvd in the contralateral eye. The retinal tear is possibly tms related given the timing in relation to the tms treatment, but is still confounded by the risk factors mentioned above. The device service records were obtained and reviewed. Results of this found that the device was functioning as intended and there were no significant or atypical services performed to the subject device that would have an affect on or cause the medical event.