InjuryOBP
NEUROSTAR
Received Sep 3, 2025 · Event occurred Aug 6, 2025
Report 3004824012-2025-00049 · MDR key 22956987
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY SYSTEM 3.6Catalog number
81-03315-000
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
61 YR · Female
- Tinnitus
- Tinnitus
Narrative
Description of Event or Problem
NEURONETICS RECEIVED A REPORT FROM A PRACTICE ALLEGING WORSENING TINNITUS DURING TMS TREATMENT DESPITE WEARING HEARING PROTECTION.
Additional Manufacturer Narrative
THE PATIENT IS CONTINUING TMS AND AS OF THE DATE OF THIS REPORT IS ON SESSION NUMBER 26 OF 36 TREATMENTS. HER WORSENING TINNITUS HAS LEVELED OFF SUCH THAT SHE IS ABLE TO GO ABOUT HER DAILY LIFE NORMALLY AND HER DEPRESSION HAS IMPROVED SIGNIFICANTLY.