Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURONETICS INC. NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEURONETICS INC. NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR Back to Search Results
Model Number 81-02315-000
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328); Depression (2361)
Event Date 05/05/2019
Event Type  Injury  
Event Description
I had transcranial magnetic stimulation treatment (tms neurostar) for depression.It did not help with the depression (which was moderate) but caused debilitating anxiety that caused me to be almost non-functional and i was hospitalized.I had 36 tms treatments (all to left side of head), about half way through i descended into a severe depression, but that only lasted a few days, and i was advised to continue the treatment.The treatment was administered by a nonprofessional medical office mgr and even the supervising psychiatrist didn't seem to have much knowledge about the potential negative side effects of tms.Outcome attributed to adverse event: suicidal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEUROSTAR
Type of Device
TRANSCRANIAL MAGNETIC STIMULATOR
Manufacturer (Section D)
NEURONETICS INC.
MDR Report Key8650831
MDR Text Key146400891
Report NumberMW5086963
Device Sequence Number1
Product Code OBP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model Number81-02315-000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/29/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ASPIRIN (162 MG); FISH OIL; GABAPENTIN ; KLONOPIN; LEVOTHYROXINE; MULTIVITAMIN ; SIMVASTATIN ; TRINTELLIX
Patient Outcome(s) Hospitalization; Life Threatening; Disability;
Patient Age57 YR
Patient Weight73
-
-