MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-19 for NEUROSTAR TMS THERAPY SYSTEM 81-00315-000 manufactured by Neuronetics, Inc..
[2323342]
Approximately 15 minutes into the tms treatment session, the pt was witnessed by the tms treater to begin to have full body shaking. The treater stopped the tms, called 911 and called the supervising psychiatrist, who arrived within one minute. The psychiatrist described the movements as being "tonic-clonic. " the movements stopped within two minutes from time of onset. The pt was noted to have post-ictal confusion, which resolved by the time the rescue squad arrived. The pt was transported to the local emergency department for assessment. Her eval in the er was unremarkable, and she had a normal head ct scan. The pt was contacted by the attending psychiatrist after her discharge from the er and was doing well. The pt was on her 10th tms session of her second course of tms therapy. She had responded well to a full tms treatment course earlier in the year, but began to have return of her depressive symptoms six weeks after the end of therapy, so another course of tms was initiated. She had tolerated the tms treatments well, other than some intermittent facial discomfort. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9259607]
The treating psychiatrist believes this event to be device related. Neurotics believes that assessment of relatedness is confounded by the use of wellbutrin, zoloft, and adderall, all of which individually have an increase risk of seizure as noted below. In addition, the pt had worked a night shift prior to her morning tms session and may have been sleep deprived. Sleep deprivation is known to lower seizure threshold. 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 wellbutrin package insert states: "bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to pt factors, clinical situations, and concomitant medications, which must be considered in selection of pts for therapy with wellbutrin xl (bupropion hydrochloride extended-release). At doses up to 300 mg/day of the sustained-release formulation of bupropion (wellbutrin sr), the incidence of seizure is approximately 0. 1% (1/1,000). " the zoloft package insert notes: "no seizures were observed among approximately 3000 patients treated with zoloft (sertraline hcl) in the development program for major depressive disorder. However, 4 pts out of approximately 1800 (220 < 18 years of age) exposed during the development program for obsessive-compulsive disorder experienced seizures, representing a crude incidence of 0. 2. " adderall carries the warning: "there is some clinical evidence that stimulants may lower the convulsive threshold in pts with prior history of seizure. In patients with prior eeg abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior eeg evidence of seizures. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2011-00004 |
| MDR Report Key | 2227082 |
| Report Source | 05 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-06-24 |
| Date Mfgr Received | 2011-06-24 |
| Device Manufacturer Date | 2009-12-11 |
| 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 |