NEUROSTAR ADVANCED THERAPY
Received Apr 24, 2024 · Event occurred May 1, 2023
Report 3004824012-2024-00012 · MDR key 19177100
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Diarrhea
- Fatigue
- Hair Loss
- Headache
- Memory Loss/Impairment
- Pain
- Brain Injury
- Anxiety
- Sleep Dysfunction
- Confusion/ Disorientation
- Suicidal Ideation
- Diarrhea
- Fatigue
- Hair Loss
- Headache
- Memory Loss/Impairment
- Pain
- Brain Injury
- Anxiety
- Sleep Dysfunction
- Confusion/ Disorientation
- Suicidal Ideation
Narrative
Additional Manufacturer Narrative
NEURONETICS RECEIVED A MEDWATCH FROM A PATIENT'S WIFE ALLEGING THE ABOVE REPORTED ADVERSE EVENTS AFTER THE PATIENT RECEIVED A TOTAL OF 46 TREATMENT SESSIONS. THE PATIENT LATER CALLED THE FDA BACK WITH FURTHER INFORMATION ON THE ALLEGED ADVERSE EVENTS. NO CONTACT INFORMATION WAS PROVIDED TO CONDUCT A THOROUGH INVESTIGATION AND THEREFORE NEURONETICS CANNOT CONFIRM THE DETAILS OF THE ALLEGED EVENTS OR CONFIRM THAT A NEUROSTAR DEVICE WAS USED TO TREAT THE PATIENT.
Description of Event or Problem
NEURONETICS RECEIVED A MEDWATCH FROM A PATIENT'S WIFE ALLEGING THAT, AFTER RECEIVING A TOTAL OF 46 TREATMENT SESSIONS, HER HUSBAND EXPERIENCED THE FOLLOWING SYMPTOMS: JAW PAIN, EXTREME ANXIETY, PACING, SEVERE INSOMNIA, "AN OUT OF MIND FEELING", HOSPITALIZATION FOR SUICIDAL IDEATION AND HYPOMANIA, SEVERE MDD, CHRONIC DIARRHEA, HEADACHE, COGNITIVE IMPAIRMENT, SEVERE BRAIN INJURY, CONFUSION, HAIR LOSS, AND FATIGUE.