InjuryOBP
NEUROSTAR ADVANCED THERAPY
Received Jul 6, 2023 · Event occurred May 22, 2023
Report 3004824012-2023-00014 · MDR key 17266345
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 3.0Catalog number
81-02315-00R
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR · Male
- Tinnitus
- Tinnitus
Narrative
Description of Event or Problem
NEURONETICS RECEIVED AN EMAIL FROM A TMS PROVIDER INDICATING THAT A PATIENT COMPLAINED OF WORSENING TINNITUS.
Additional Manufacturer Narrative
PATIENT WAS OBSERVED "HOLDING EARS" ON 3RD OR 4TH TREATMENT AND COMPLAINED OF LOUD RINGING IN THE EARS. PATIENT WAS USING HEARING PROTECTION DURING TREATMENTS. PATIENT DECIDED TO STOP TREATMENT AFTER 8TH SESSION. IT IS NOT KNOWN IF THE PATIENT HAS SOUGHT ATTENTION FROM A MEDICAL SPECIALIST.