MAUDE Adverse Event Report: NEURONETICS INC. NEURO STAR TMS THERAPY; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Headache (1880); Pain (1994); Tinnitus (2103); Anxiety (2328)

Event Date 02/15/2021

Event Type  Injury  

Event Description

Had tms treatment at (b)(6) it was very painful, have lasting severe headaches after just 2 treatments, since having just 2 treatments have had an overwhelming sense of sadness, my anxiety has worsened, i'm experiencing terrible mood swings.The ringing in my ears is unbearable.Fda safety report id # (b)(4).

• Brand Name: NEURO STAR TMS THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 11404299
• MDR Text Key: 234936498
• Report Number: MW5099746
• Device Sequence Number: 1
• Product Code: OBP
• 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: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR