NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED FURTHER INFORMATION RELATED TO MDR 3004824012-2024-00011 FROM THE PROVIDER'S OFFICE CLARIFYING THE DEVICE THE PATIENT WAS TREATED WITH WHEN THE EVENT OCCURRED. THE OFFICE HAS SEVERAL DEVICES AND THE PREVIOUS MDR SUBMITTED CONTAINED THE INCORRECT DEVICE INFORMATION. THIS REPORT CONTAINS THE CORRECT DEVICE INFORMATION.

Additional Manufacturer Narrative

PROVIDER CONTACTED NEUROMETRICS TO REPORT THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR 8TH TREATMENT SESSION. EMS WAS CALLED AND THE PATIENT WAS TAKEN TO THE ER, HOWEVER PATIENT LEFT BEFORE BEING EVALUATED DUE TO LONG WAIT TIME. PATIENT HAS A PREVIOUS HISTORY OF SEIZURES AND HAS BEEN DOCUMENTED WITH A DIAGNOSIS OF GENERALIZED CONVULSIVE EPILEPSY BY A PREVIOUS PROVIDER BUT THIS CONDITION HAS REPORTEDLY BEEN RESOLVED. PATIENT IS CURRENTLY ON SEVERAL MEDICATIONS THAT COULD IMPACT HIS SEIZURE THRESHOLD, INCLUDING ZOLOFT, ZIPRASIDONE, CLOMIPRAMINE, AND ATIVAN. PATIENT ALSO HAS AUTISM WHICH IS A RISK FACTOR FOR SEIZURES. PATIENT HAS CURRENTLY STOPPED TMS AND HAS AN UPCOMING APPOINTMENT WITH A NEUROLOGIST FOR EVALUATION. DUE TO THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS, IT IS UNCLEAR IF TMS CONTRIBUTED TO THE SEIZURE.

Description of Event or Problem

NEUROMETRICS RECEIVED A CALL FROM A PROVIDER REPORTING ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING HIS 8TH TREATMENT SESSION. EMS WAS CALLED FOLLOWING THE EVENT AND PATIENT WAS TAKEN TO THE ER.