NEUROSTAR ADVANCED THERAPY
Received Jul 17, 2026 · Event occurred Aug 7, 2024
Report 3004824012-2026-00019 · MDR key 25861895
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Fatigue
- Headache
- Nausea
Narrative
Additional Manufacturer Narrative
PATIENT FILED A MEDWATCH (MW5188788) INDICATING THAT SHE EXPERIENCED NAUSEA, EXTREME FATIGUE, AND MIGRAINE FROM THE START OF HER TMS TREATMENT. SHE STATES THAT THERE HAS BEEN NO RELIEF FOR ALMOST 2 YEARS. SHE INDICATES THAT SHE ALSO FELT THERE WAS A WORSENING OF SYMPTOMS (DEPRESSION, ANXIETY AND MOSTLY MIGRAINES), FATIGUE, AND MEMORY LOSS/MENTAL ACUITY (SHARPNESS). THE PATIENT SAID THAT HER ISSUES STARTED AFTER RECEIVING TMS. THE PATIENT RESPONDED VIA EMAIL TO NNI'S OUTREACH FOR INFORMATION. NNI'S TRAKSTAR DATABASE INDICATES THE PATIENT INITIALLY SAW DEPRESSION AND ANXIETY IMPROVEMENT BUT ENDED TREATMENT BACK AT HER BASELINE, WHICH INDICATES SHE DID NOT SEE BENEFIT FROM TMS THERAPY. THE CLINICAL DATA SHOWS THAT TMS TREATMENT DOESN'T WORK FOR EVERYONE. HER SCORES AT A 4-MONTH FOLLOW-UP SHOWED THAT HER DEPRESSION AND ANXIETY HAD WORSENED, WHICH CAN OCCUR WHEN SOMEONE DOES NOT SEE BENEFIT FROM TMS (LOSS OF HOPE IN A TREATMENT). THE TREATING PRACTICE INDICATED THAT THE PATIENT NOTED A FEW WEEKS POST-TMS THAT SHE WAS CONTINUING TO FEEL BETTER WITH SIGNIFICANTLY FEWER MIGRAINES AND BECAUSE OF THAT HAD MORE ENERGY AND BETTER MOOD. THE PATIENT IS CONTINUES TO SEE PROVIDERS IN THE OFFICE FOR THERAPY AND MED MANAGEMENT, AND THE RECENT NOTES DO NOT INDICATE THAT THE PATIENT HAS MENTIONED THE COMPLAINTS. NEURONETICS IS UNABLE TO DETERMINE SPECIFIC RELATIONSHIP OF TMS TO HER WORSENING DEPRESSION/ANXIETY AND MIGRAINES, ALTHOUGH THE PATIENT FEELS IT IS DUE TO TMS. DUE TO THE NATURE OF HER COMPLAINTS, NNI IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
PATIENT FILED A MEDWATCH REPORT STATING THAT SHE HAD TMS TREATMENT AND FROM THE VERY START EXPERIENCED EXTREME FATIGUE, NAUSEA, AND A MIGRAINE. SHE STATED SHE SAW A WORSENING OF SYMPTOMS (MDD AND ANXIETY), MEMORY LOSS, AND A DECREASE IN MENTAL SHARPNESS (FEELS SLOWER TRYING TO THINK OR RECALL MEMORIES, WORDS, OR OTHER INFORMATION). SHE STATED THAT SHE HAD A MIGRAINE EVERY SINGLE DAY SINCE STARTING TREATMENT. SHE STATED THAT SHE HAS NOT HAD ANY RELIEF FROM THESE SYMPTOMS AND FEELS LIKE SHE HAS ONLY GOTTEN WORSE, NOT BETTER.