NEUROSTAR ADVANCED THERAPY

Additional Manufacturer Narrative

NEURONETICS RECEIVED A MEDWATCH FROM A PATIENT ALLEGING TO HAVE EXPERIENCED THE ABOVE REPORTED ADVERSE EVENTS AFTER RECEIVING A TOTAL OF 36 TREATMENTS. NEURONETICS ATTEMPTED TO CONTACT THE PATIENT WITH THE INFORMATION PROVIDED ON THE MEDWATCH MULTIPLE TIMES (EMAIL/PHONE/FEDEX'D LETTER) TO OBTAIN FURTHER INFORMATION AND WAS UNSUCCESSFUL. IN AN ATTEMPT TO OBTAIN ADDITIONAL CONTACT INFORMATION, NEURONETICS DISCOVERED THE PATIENT'S BLOG WHICH DETAILS HER BATTLE WITH DEPRESSION. BASED ON THE INFORMATION PROVIDED IN THE BLOG, THE PATIENT REPORTEDLY HAS HAD SEVERE DEPRESSION MOST OF HER LIFE AND HAS FAILED VARIOUS TREATMENTS INCLUDING KETAMINE AND NAD INFUSIONS. PER THE PATIENT'S BLOG, SHE REPORTEDLY RECEIVED TMS IN SPOKANE, WASHINGTON. ALL NEUROSTAR TMS PROVIDERS WERE CONTACTED, AND NONE HAD TREATED HER. NEURONETICS IS UNABLE TO CONFIRM WHETHER A NEUROSTAR DEVICE WAS USED TO TREAT THE PATIENT.

Description of Event or Problem

NEURONETICS RECEIVED A MEDWATCH FROM A PATIENT WHICH CLAIMED THAT AFTER RECEIVING A TOTAL OF 36 TREATMENTS, THE PATIENT EXPERIENCED THE FOLLOWING: SEVERE PAIN, RIGHT UPPER EXTREMITY TETANY, INCREASED DEPRESSION AND ANXIETY, INCREASED SUICIDAL IDEATION, NEW ONSET SELF HARM, AND WORSENING OF TBI SYMPTOMS. PATIENT CLAIMS THAT SHE WAS HOSPITALIZED AS A RESULT OF THE ALLEGED SYMPTOMS.