NEUROSTAR ADVANCED THERAPY
Received Apr 16, 2026 · Event occurred Feb 27, 2026
Report 3004824012-2026-00014 · MDR key 24903600
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
40 YR · Male
- Emotional Changes
Narrative
Additional Manufacturer Narrative
PATIENT RECEIVED 3 MDD TREATMENTS THEN HAD OCD TREATMENT ADDED. AFTER THE PATIENT'S 3RD OCD TREATMENT, THE PATIENT BEGAN TO EXPRESS MANY COMPLAINTS (LISTED TOTAL OF 63). BOTH THE PRACTICE AND THE PATIENT ATTRIBUTED THE COMPLAINTS TO HIS PRE-EXISTING TYPE OF OCD IN WHICH HE FIXATES ON THINGS HE CANNOT SEE THAT ARE HAPPENING INSIDE HIS BODY. FOR EXAMPLE, HE STARTED TO HAVE AN INTRUSIVE FEAR THAT THE TMS WAS GOING TO HURT HIS BRAIN. WHEN OFFICE MANAGER OF THE PRACTICE SPOKE WITH HIM ON THE PHONE ON (B)(6) 2026, HE WAS STILL EMPLOYED AND PARTICIPATING IN TRAVEL FOR WORK. COMPLAINT HAS NOT RESOLVED. ON (B)(6) 2026, NNI REQUESTED A STATUS FROM THE PATIENT WHO STATED THAT HE THINKS HIS COMPLAINTS ALSO REVOLVE AROUND THE MDD TREATMENT. IN ADDITION, THE PATIENT EXPERIENCED PANIC ATTACKS WHICH HE HAD NOT HAD SINCE 2014. HE HAS NOT NOTED HAVING ANY FURTHER PANIC ATTACKS. HE TOLD THE OFFICE MANAGER THAT HE WENT BACK TO THE OFFICE WHERE HE HAD RECEIVED PREVIOUS FULL COURSE OF TMS FOR MDD. ACCORDING TO THE PATIENT, HE CONTINUED WITH MDD TREATMENT AT ANOTHER PRACTICE BUT DID NOT ADD OCD.
Description of Event or Problem
PATIENT EMAILED THE PRACTICE AND NNI DIRECTLY BUT SEPARATELY REGARDING A VERY LONG LIST OF COMPLAINTS THAT HE FELT ARE RELATED TO TMS TREATMENT. THE PATIENT LISTED A LARGE NUMBER OF ISSUES WHICH WHEN REVIEWED SHOWED A WORSENING OF OCD AND POSSIBLY MDD SYMPTOMS WHICH APPEAR TO HAVE STARTED AFTER HAVING OCD ADDED TO THE MDD TREATMENT.
Additional Manufacturer Narrative
RELATED TO MEDWATCH # MW5187174.