InjuryOBP
NEUROSTAR
Received Jun 23, 2025
Report 3004824012-2025-00036 · MDR key 22311539
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Female
- Emotional Changes
- Emotional Changes
Narrative
Description of Event or Problem
NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT DID NOT WORK AND SYMPTOMS GOT WORSE AS A RESULT OF TMS TREATMENT.
Additional Manufacturer Narrative
THE PERSON WHO POSTED THE ALLEGED ADVERSE EVENT DID NOT RESPOND TO A REQUEST TO CONTACT NEURONETICS' CUSTOMER SERVICE TO OBTAIN ADDITIONAL INFORMATION. NEURONETICS WAS NOT ABLE TO DO A THOROUGH INVESTIGATION DUE TO THE LIMITED INFORMATION. HOWEVER, NEURONETICS IS SUBMITTING OUT OF AN ABUNDANCE OF CAUTION GIVEN THE ALLEGATION OF A POTENTIAL SERIOUS ADVERSE EVENT.