NEUROSTAR ADVANCED THERAPY
Received Feb 9, 2026 · Event occurred Jan 12, 2026
Report 3004824012-2026-00004 · MDR key 24298899
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
21 YR · Female
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
THE PATIENT HAD RECEIVED 28 TREATMENTS FOR DEPRESSION (MDD) AND 26 FOR OCD. PATIENT'S FAMILY HAD COME TO TOWN TO CHECK ON THEM AND HAD GIVEN AN ULTIMATUM OF GOING INTO AN INTENSIVE OUTPATIENT PROGRAM OR THEY WOULD BE CUT OFF FINANCIALLY. THE PATIENT DID NOT SHOW UP FOR THE MONDAY MORNING TMS APPOINTMENT, AND THE FATHER NOTIFIED THE PRACTICE THAT THE PATIENT HAD ATTEMPTED SUICIDE. THE PATIENT STAYED IN THE HOSPITAL FOR A WEEK, IS NOW PHYSICALLY OKAY, AND ENTERED AN INTENSIVE OUTPATIENT PROGRRAM. PRIOR TO TMS, THE PATIENT HAD SUICIDAL IDEATION WITHOUT A PLAN AND DID NOT COMMUNICATE OTHERWISE DURING HER COURSE OF TREATMENT. THE PATIENT'S PHQ9 PRIOR TO TMS WAS ALREADY THE MAXIMUM SCORE AND INDICATING SUICIDAL IDEATION. THE SCORE DECREASED BUT WENT BACK TO THE MAXIMUM SCORE RIGHT BEFORE ATTEMPTING SUICIDE. IT IS UNCLEAR WHETHER TMS CAUSED OR CONTRIBUTED TO THE ATTEMPTED SUICIDE SINCE OTHER FACTORS WERE PRESENT AS WELL.
Description of Event or Problem
PATIENT ATTEMPTED SUICIDE IN THEIR HOME. THE PRACTICE NOTED THAT THE PATIENT HAD WORSENING ANXIETY, OCD, AND SUCIDAL IDEATION PRIOR TO THE ATTEMPT, BUT THEIR LAST DEPRESSION SCORES DID NOT WORSEN ABOVE THEIR BASELINE SCORE.