NEUROSTAR ADVANCED THERAPY SYSTEM

Additional Manufacturer Narrative

THE MEDWATCH REPORT INCLUDED CONTACT INFORMATION ENABLING NEURONETICS TO FOLLOW UP WITH THE PATIENT'S MOTHER AND THE PROVIDER. OTHER THAN MILD, TRANSIENT HEADACHE, THE REPORTED SYMPTOMS OF DIZZINESS AND AMBULATION/POSTURAL DIFFICULTIES ARE NOT TYPICAL SIDE EFFECTS OF TMS. THE PATIENT'S PROVIDER NOTED THAT THE PATIENT HAS HAD SIDE EFFECTS FROM MOST MEDICATIONS AND THAT THERE COULD BE OTHER OUTSIDE FACTORS IMPACTING THE PATIENT. THE PATIENT DISCONTINUED TREATMENT AFTER THE 19TH SESSION. THE TMS PROVIDER REFERRED THE PATIENT TO A PEDIATRIC NEUROLOGIST WHO SUGGESTED SHE MAY HAVE A FUNCTIONAL DISORDER AND SCHEDULED HER FOR AN MRI IN MAY 2025. THE PATIENT'S MOTHER REPORTED SHE HAS IMPROVED, WITH THE EXCEPTION OF THE WEAKNESS IN HER LEGS, SINCE TMS TREATMENT STOPPED. THERE IS NO EVIDENCE TO DETERMINE IF THE PATIENT'S HEALTH COMPLAINTS ARE DUE TO TMS TREATMENT OR ANOTHER HEALTH ISSUE.

Description of Event or Problem

NEURONETICS RECEIVED MEDWATCH (MW) 5163619 FROM FDA VIA EMAIL ON JANUARY 6, 2025. THE MW WAS REPORTED BY THE MOTHER OF A FEMALE PATIENT WHO ALLEGES HEADACHES, DIZZINESS, AND UNSTEADINESS/LEG WEAKNESS AFTER RECEIVING 19 NEUROSTAR ADVANCED THERAPY TMS TREATMENTS. ABOUT A WEEK AFTER THE SYMPTOMS APPEARED THE PATIENT FELL AND WAS TAKEN TO THE ER FOR TESTING.