MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-23 for NEUROSTAR TMS SYSTEM NEUROSTAR TMS 1.0 81-60000-000 manufactured by Neuronetics Inc..
[20511225]
Pt experienced a generalized, tonic-clonic seizure. The seizure occurred approx 8 minutes after the pt's 10th tms treatment session. The seizure began with movements in her right arm, and then progressed proximally, until it was observed to have resulted in generalization with tonic-clonic movements of all four extremities. The seizure duration was approx 60 seconds, and terminated without intervention. Shortly after cessation of the seizure, pt was reported to be oriented to person and place. She was transported to a local emergency room (er) by ambulance within 10 minutes of the onset of the seizure. Her history within the emergency room was as described above, at which time she reported feeling tired, but had no complaints of numbness, tingling or weakness. Her vital signs at eval in the er were t 98. 5, r 22, p 118, bp 118/69, with an oxygen saturation of 99% on room air. Her physical exam was unremarkable and she had a normal neurologic exam. A cbc and chemistry panel were reported as normal. She had a normal urine drug screen with the exception of the presence of the psychotropic medications she was known to be administered. A non-contrast ct scan of her head was reported as normal.
Patient Sequence No: 1, Text Type: D, B5
[20817188]
Seizure is a rare adverse event reported with tms therapy (see neurostar tms therapy system product labeling). A small number of seizures have been reported in the literature with investigational use of tms; no seizures were reported in over 10,000 treatments with the neurostar tms system in clinical trials. The pt in this report experienced a generalized tonic-clonic seizure. It is notable that the pt was taking several medications known to reduce seizure threshold (pamelor, pristiq, loxitane, abilify, klonopin). The pt was discharged from the er in good condition; a neurological consult is pending at the time of this report. Add'l training of site personnel on device use, including coil positioning, was conducted on 12/18/2009 as a remedial action. A field notification will be issued within 30 days to customers to highlight the potential risk of seizure and the need for correct device use in coil positioning and treatment. Conclusion: the neurostar and pdms are working within specification. The a/p bar locations recorded by the user in the pdms for this pt's treatments would not have advanced the coil sufficiently to position the coil over the prefrontal cortex (the correct treatment location).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2009-00002 |
| MDR Report Key | 1566922 |
| Report Source | 05 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-12-23 |
| Date of Event | 2009-12-16 |
| Date Mfgr Received | 2009-12-16 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-04-09 |
| 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 | JUDY WAYS, PH.D., V.P. |
| Manufacturer Street | 31 GENERAL WARREN BOULEVARD |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6109814107 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION SYSTEM |
| Product Code | OBP |
| Date Received | 2009-12-23 |
| Model Number | NEUROSTAR TMS 1.0 |
| Catalog Number | 81-60000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS INC. |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-23 |