MAUDE Adverse Event Report: NEURONETICS INC. TMS NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR

Patient Problems Pain (1994); Anxiety (2328); Depression (2361); Suicidal Ideation (4429); Unspecified Mental, Emotional or Behavioural Problem (4430); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/20/2022

Event Type  Injury  

Event Description

Completed 36 sessions of tms which caused severe pain, right upper extremity tetany, increased depression and anxiety, increased si, and new onset self harm.I ended up having to do inpatient psychiatric hospitalization due to these effects.Worsening of tbi symptoms also occurred.

• Brand Name: TMS NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 18747987
• MDR Text Key: 335878358
• Report Number: MW5151784
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AMBIEN; IBUPROFEN; KRILL OIL; MAGNESIUM; MULTI-VITAMIN; UNISOM; VIT D ; VYVANSE ; ZOLOFT
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White