NEUROSTAR ADVANCED THERAPY
Received Sep 14, 2023 · Event occurred Aug 10, 2023
Report 3004824012-2023-00021 · MDR key 17748857
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY V3.0Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Dizziness
- Dizziness
Narrative
Description of Event or Problem
NEURONETICS RECEIVED AN EMAIL FROM A TMS PROVIDER REPORTING THAT ONE OF THEIR PATIENTS WAS EXPERIENCING DIZZINESS WHICH IN TURN LED TO HER FALLING AND HURTING HER SHOULDER.
Additional Manufacturer Narrative
A TMS PROVIDER CONTACTED NEURONETICS TO ASK IF DIZZINESS IS ASSOCIATED WITH TMS TREATMENT. THE PATIENT HAD 10 SESSIONS WHEN THE COMPLAINT WAS NOTED. THE TREATER STATED THAT THE PATIENT FEELS LIKE SHE'S HAVING MORE TROUBLE AFTER TREATMENT FINDING HER BALANCE THAN NORMAL. THE WEEK PRIOR TO THE DATE OF THE COMPLAINT, THE PATIENT STATED THAT SHE HAD FALLEN WHEN SHE BENT DOWN TO PICK SOMETHING UP AND HURT HER SHOULDER. THE EMAIL FROM THE TREATER INDICATES THAT THE PATIENT HAS PRE-EXISTING BALANCE ISSUES AND ISSUES WITH DIZZINESS AS A RESULT OF A TRAUMATIC BRAIN INJURY. IT IS UNKNOWN IF THE PATIENT HAD TO SEEK MEDICAL ATTENTION IN RELATION TO THE FALL. NEURONETICS HAS ATTEMPTED TO OBTAIN FURTHER INFORMATION FROM THE TMS PROVIDER ON THE REPORTED DIZZINESS AND FALL BUT HAS BEEN UNSUCCESSFUL. BASED ON THE INFORMATION PRESENT, NEURONETICS IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE INCREASE IN DIZZINESS.