NEUROSTAR

Additional Manufacturer Narrative

PATIENT INITIALLY HAD 11 TMS TREATMENTS ON A MAGSTIM DEVICE AND THEN WAS SWITCHED TO A NEUROSTAR DEVICE FOR THE FOLLOWING 22 TREATMENT SESSIONS. THE PATIENT MENTIONED THAT SHE HAD NOT HAD ANY FOOD OR WATER BEFORE HER TREATMENT. SHE ALSO DID NOT HAVE HER USUAL CAFFEINE THE MORNING OF THE SEIZURE. THE PATIENT LATER INFORMED THE PROVIDER THAT SHE WAS NEWLY PREGNANT AND DECIDED TO DISCONTINUE TREATMENT. THE PROVIDER STATED THAT POTENTIAL DEHYDRATION AND RECENT COMPLETION OF AMOXICILLIN ON (B)(6) 2024 MAY HAVE CONTRIBUTED TO THE SEIZURE. PLEASE NOTE THAT THIS IS BEING SUBMITTED LATE AFTER A REVIEW OF THE FILE REVEALED THAT A SUPPLEMENT TO THE INITIAL FILING IN 2024 WAS NOT SUCCESSFUL. THE ORIGINAL FORM HAD A TYPO AND FAILED SUBMISSION SO A SUPPLEMENT WAS FILED TO CORRECT THE MDR NUMBERING TYPO. ACKNOWLEDGEMENTS WERE RECEIVED BUT IT WAS NOT NOTED THAT THERE WAS ANOTHER FAILURE UNTIL (B)(6) 2025.

Description of Event or Problem

PRACTICE CALLED NEURONETICS TO REPORT THAT PATIENT HAD A SEIZURE DURING TREATMENT. PATIENT REFUSED MEDICAL ATTENTION, THE SEIZURE SELF-RESOLVED, AND THEY REPORTED FEELING FINE FOLLOWING THE EVENT.