NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

A PROVIDER CONTACTED NEURONETICS TO REPORT THAT THEY HAD LEARNED THAT ONE OF THEIR PAST PATIENTS HAD ATTEMPTED SUICIDE AND HAS BEEN HOSPITALIZED. THE PROVIDER WAS INFORMED OF THIS FROM THE PATIENT'S TREATING PSYCHIATRIST. THE EVENT OCCURED OVER A MONTH AFTER PATIENT HAD FINISHED HER COURSE OF TMS. PATIENT HAD REPORTEDLY EXPERIENCED A FAMILY TRAGEDY DURING HER COURSE OF TREATMENT. PER THE PROVIDER, PATIENT HAD BEEN GETTING BETTER THROUGHOUT TREATMENT BUT THIS EVENT HAD "DERAILED" THE PATIENT'S PROGRESS AND THE PROVIDER HAD DECIDED TO EXTEND HER TREATMENT COURSE AS A RESPONSE. PATIENT HAD REPORTEDLY BEEN HAVING GENERAL SUICIDAL IDEATION PRIOR TO STARTING TMS AND HER PHQ-9 SCORES INDICATED THAT SHE HAD BEEN EXPERIENCING SUICIDAL IDEATION DURING TREATMENT AS WELL. NEURONETICS HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION FROM THE PATIENT'S TREATING PSYCHIATRIST TO DETERMINE WHAT HAD LED TO THE EVENT AND IF THE PATIENT HAS HAD A PRIOR HISTORY OF SUICIDE ATTEMPTS. NEURONETICS IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT AND IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS ATTEMPTED SUICIDE OVER A MONTH AFTER FINISHING HER TMS TREATMENT COURSE AND WAS SUBSEQUENTLY HOSPITALIZED.