NEUROSTAR
Received May 27, 2025
Report 3004824012-2025-00027 · MDR key 22088381
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Emotional Changes
- Headache
- Visual Impairment
- Dizziness
- Brain Injury
- Movement Disorder
- Emotional Changes
- Headache
- Visual Impairment
- Dizziness
- Brain Injury
- Movement Disorder
Narrative
Additional Manufacturer Narrative
THE PATIENT FINALLY RESPONDED ON (B)(6) 2025 TO AN EMAIL SENT ON (B)(6) 2025 AND PROVIDED THE PRACTICE NAME WHERE THEY WERE TREATED. ON (B)(6) 2025, THE PRACTICE WAS CONTACTED AND IT WAS CONFIRMED THAT THE PRACTICE HAD REPORTED MIGRAINE SYMPTOMS TO NEURONETICS IN (B)(6) OF 2023. NEURONETICS SUBMITTED MDR 3004824012-2023-00024 TO FDA ON (B)(6) 2023. IN 2023 THE PATIENT HAD ONLY REPORTED AN INCREASE IN MIGRAINE. HOWEVER, THE MEDWATCH (MW5169340) REPORTED IN 2025 ALLEGES OTHER ADVERSE EFFECTS THAT COULD NOT BE CORROBORATED BY THE PRACTICE. THEREFORE MDR 3004824012-2023-00024 AND MDR 3004824012-2025-00027 ARE FOR THE SAME PATIENT AND TREATMENT COURSE.
Description of Event or Problem
NEURONETICS RECEIVED A MEDWATCH (MW5169340) FROM FDA IN WHICH A PATIENT ALLEGES THEY EXPERIENCED SEVERE PAIN, MOTOR COORDINATION ISSUES, PERSISTENT HEADACHES, DIZZINESS AND SENSE OF EMOTIONAL DETATCHMENT.
Additional Manufacturer Narrative
THE PATIENT PROVIDED THEIR CONTACT INFORMATION IN THE MEDWATCH REPORT BUT DID NOT RESPOND TO MULTIPLE ATTEMPTS OF COMMUNICATION. BASED ON THE INFORMATION PROVIDED, NEURONETICS IS UNABLE TO CONFIRM THE PATIENT WAS TREATED ON A NEUROSTAR DEVICE AND CONDUCT A THOROUGH INVESTIGATION WITH THE TREATING PRACTICE. OTHER THAN HEADACHES, THE SYMPTOMS EXPERIENCED ARE NOT COMMONLY ASSOCIATED WITH TMS TREATMENT AND NO CONCLUSION CAN BE MADE REGARDING RELATEDNESS.