InjuryOBP
NEUROSTAR
Received May 16, 2025
Report 3004824012-2025-00014 · MDR key 22036657
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Suicidal Ideation
- Suicidal Ideation
Narrative
Description of Event or Problem
NEURONETICS' SOCIAL MEDIA MONITOR FORWARDED A POST ALLEGING TMS TREATMENT LEAD TO SUICIDALITY.
Additional Manufacturer Narrative
SINCE THE REPORTER DID NOT RESPOND TO NEURONETICS' ATTEMPTED OUTREACH FOR ADDITIONAL INFORMATION, IT WAS IMPOSSIBLE TO CONDUCT A THOROUGH INVESTIGATION AND CONFIRM THAT THE PERSON WAS TREATED WITH A NEUROSTAR DEVICE. IN THE POST THE PATIENT MENTIONED HAVING BIPOLAR DISORDER WHICH IS A CONTRAINDICATION FOR TMS. BASED ON THE INFORMATION PROVIDED NO CAUSE CAN BE ATTRIBUTED BUT REPORTING OUT OF AN ABUNDANCE OF CAUTION.