NEUROSTAR ADVANCED THERAPY
Received May 18, 2023 · Event occurred Apr 20, 2023
Report 3004824012-2023-00012 · MDR key 16954645
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 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
55 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER INDICATING THAT A PATIENT FELT NAUSEOUS AND HAD THREE (3) FOCAL SEIZURES THE EVENING AFTER HER 33RD TMS TREATMENT. THE PATIENT WENT TO THE EMERGENCY ROOM THE FOLLOWING MORNING AN HAD A GRAND MAL SEIZURE. THE PATIENT WAS NOT HOSPITALIZED BUT WAS PRESCRIBED KEPPRA. SHE WAS ADVISED TO SEE A NEUROLOGIST FOR FOLLOW UP.
Additional Manufacturer Narrative
KNOWN RISK FACTORS FOR PATIENT INCLUDE FAMILY HISTORY OF EPILEPSY (DAUGHTER DIAGNOSED WITH EPILEPSY), HISTORY OF TAKING SEIZURE THRESHOLD LOWERING MEDICATIONS (ABILIFY AND PROZAC), AND A FEBRILE ILLNESS AT TIME OF TREATMENT AND SUBSEQUENT SEIZURES. ADDITIONAL RISK FACTORS FOR SEIZURES SUCH AS DEHYDRATION, LACK OF SLEEP, ALCOHOL, CAFFEINE, OR ILLICIT DRUG USE, WERE NOT ABLE TO BE OBTAINED. WHILE A DEFINITIVE CAUSE CANNOT BE ESTABLISHED, THE PATIENT'S KNOWN RISK FACTORS LIKELY PREDISPOSED HER TO THE SEIZURE EVENT.