NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

PROVIDER'S OFFICE CALLED NEURONETICS TO REPORT THAT THEIR PATIENT'S MOTHER IS CONCERNED THAT THE PATIENT (HER SON) HAS EXPERIENCED A SIGNIFICANT WORSENING IN HIS OCD SYMPTOMS AFTER RECEIVING 16 TREATMENTS. THE PATIENT HAS REPORTEDLY BEEN STAYING UP "ALL NIGHT MAKING LISTS AND CHECKING THEM OVER AND OVER, NOT SLEEPING".

Additional Manufacturer Narrative

NEURONETICS RECEIVED A CALL FROM A PROVIDER'S OFFICE REGARDING A PATIENT'S MOTHER THAT REPORTED THE PATIENT HAD EXPERIENCED A WORSENING IN HIS OCD SYMPTOMS AFTER RECEIVING 16 TREATMENTS. PER THE PATIENT'S MOTHER, THE PATIENT HAD NOT BEEN SLEEPING AND HAD BEEN "MAKING LISTS" ALL NIGHT AND CHECKING THEM "OVER AND OVER". THE PROVIDER NOTED THAT THE INCREASE IN THE PATIENT'S SYMPTOMS HAVE BEEN A RESULT OF HAVING TO COME INTO THE OFFICE EVERYDAY TO RECEIVE TREATMENT WHICH HAS DISRUPTED HIS ROUTINE AS HIS DAILY ROUTINE HAS BEEN SHIFTED TO ACCOMMODATE TREATMENT. PATIENT RECEIVED 4 MORE TREATMENTS (20 TREATMENTS TOTAL) BEFORE DISCONTINUING TMS. AT THE TIME OF DISCONTINUATION, THE PATIENT REPORTEDLY BEGAN HAVING "AN INCREASE IN RACING THOUGHTS AND ISSUES WITH CONCENTRATION IN SCHOOL" WHICH WAS NOT PRESENT AT THE BEGINNING OF TREATMENT. SINCE DISCONTINUING TMS, THE PATIENT REPORTED THAT HIS OCD SYMPTOMS HAVE GONE BACK TO HOW THEY WERE BEFORE TMS BUT HIS THERAPIST NOTED THAT THE PATIENT IS STILL FEELING EMOTIONALLY DISREGULATED FOLLOWING TMS AS HE HAS EXHIBITED AN INCREASE IN CHECKING AND PLANNING BEHAVIORS BUT THIS "MAY BE DUE TO EXTERNAL FACTORS". THE PATIENT WAS BEING TREATED OFF-LABEL FOR OCD AS PATIENT IS NOT CURRENTLY ON ANY MEDICATIONS AND IS AN ADOLESCENT. NEURONETICS IS REPORTING OUT OF AN ABUNDANCE OF CAUTION AS IT IS UNCLEAR AS TO WHAT MAY HAVE CONTRIBUTED TO THE PATIENT'S REPORTED SYMPTOMS.