InjuryOBP
NEURUOSTAR ADVANCED THERAPY
Received Apr 12, 2023 · Event occurred Feb 20, 2023
Report 3004824012-2023-00008 · MDR key 16723649
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPYCatalog number
3.0
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Female
- Tinnitus
- Tinnitus
Narrative
Additional Manufacturer Narrative
PATIENT CLAIMS TO HAVE HAD TINNITUS BEFORE STARTING TMS TREATMENT BUT CHANGED FROM "WHITE NOISE" TO A "RINGING NOISE" AFTER HER SECOND TREATMENT. IT IS UNKNOWN IF THE PATIENT WAS SEEN BY A SPECIALIST. THE TREATING PHYSICIAN DID NOT THINK THAT THE SYMPTOMS WERE DUE TO THE TMS TREATMENT.
Description of Event or Problem
A NEUROSTAR TMS PROVIDER CONTACTED NEURONETICS TO REPORT A PATIENT CLAIMING THEIR TINNITUS HAD WORSENED SINCE STARTING TMS TREATMENT.