InjuryOBP
NEUROSTAR ADVANCED THERAPY SYSTEM
Received Sep 16, 2025 · Event occurred Aug 12, 2025
Report 3004824012-2025-00055 · MDR key 23068892
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
26 YR · Female
- Headache
- Headache
Narrative
Description of Event or Problem
NEURONETICS RECEIVED INFORMATION FROM A PRACTICE REGARDING A PATIENT THAT STARTED HAVING PERSISTENT MIGRAINES AFTER TMS TREATMENT NUMBER 17, THE PATIENT WENT TO THE ER TWICE DUE TO THE MIGRAINES BUT THEY WERE UNABLE TO DETERMINE THE CAUSE OR RULE OUT TMS AS THE CAUSE AND REFERRED HER TO A NEUROLOGIST. THE PATIENT REPORTS NOT BEING ABLE TO WORK AS A RESULT OF THE MIGRAINES.
Additional Manufacturer Narrative
DURING THE PATIENT'S ER VISITS, THEY COULD NOT RULE OUT TMS AS A CAUSE FOR HER MIGRAINES, HOWEVER THE PATIENT HAS CONTINUED TMS TREATMENT SINCE HER DEPRESSION HAS IMPROVED.