NEUROSTAR TMS SYSTEM NEUROSTAR TMS 1.0 81-60000-000

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3004824012-2009-00002
MDR Report Key1566922
Report Source05
Date Received2009-12-23
Date of Report2009-12-23
Date of Event2009-12-16
Date Mfgr Received2009-12-16
Device Manufacturer Date2009-05-01
Date Added to Maude2010-04-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJUDY WAYS, PH.D., V.P.
Manufacturer Street31 GENERAL WARREN BOULEVARD
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6109814107
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEUROSTAR TMS SYSTEM
Generic NameTRANSCRANIAL MAGNETIC STIMULATION SYSTEM
Product CodeOBP
Date Received2009-12-23
Model NumberNEUROSTAR TMS 1.0
Catalog Number81-60000-000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNEURONETICS INC.
Manufacturer AddressMALVERN PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-12-23

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