NEUROSTAR ADVANCED THERAPY SYSTEM
Received Feb 25, 2025 · Event occurred Nov 22, 2024
Report 3004824012-2025-00005 · MDR key 21463043
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 3.0Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
29 YR · Male
- Eye Pain
- Eye Pain
Narrative
Description of Event or Problem
NEURONETICS WAS MADE AWARE BY A TMS PRACTICE THAT A MALE PATIENT HAD EYE PAIN AND TWITCHING THAT STARTED ABOUT MIDWAY THROUGH HIS 36 TREATMENT COURSE AND CONTINUES AFTER TREATMENT WAS COMPLETED.
Additional Manufacturer Narrative
PATIENT HAD NEUROLOGICAL TESTING AND OPTHOMOLOGY APPOINTMENT TO DETERMINE CAUSE OF EYE PAIN AND TWITCHING BUT RESULTS WERE NORMAL. SOME CHANGES TO THE PATIENT TREATMENT SETTINGS, TO ADDRESS DISCOMFORT, ARE NOT CONSIDERED NORMAL PROTOCOL. THE PATIENT DID FINISH THE COURSE OF TMS TREATMENT AND HAD IMPROVEMENT IN HIS DEPRESSION. A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOMS AND THE TMS TREATMENT CAN NOT BE RULED OUT BASED ON THE EXISTING INFORMATION. THEREFORE, REPORTING OUT OF AN ABUNDANCE OF CAUTION.