MAUDE Adverse Event Report: NEURONETICS NEUROSTAR TMS THERAPY SYSTEM; TRANSCRANIAL MAGNETIC STIMULATION SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Hearing Impairment (1881); Tinnitus (2103); Therapeutic Response, Decreased (2271)

Event Date 08/31/2015

Event Type  Injury  

Event Description

Starting from (b)(6) 2015 i underwent treatment for depression using repetitive transcranial magnetic stimulation (rtms) for one hour, five days a week, for six weeks.This was using the neurostar machine.After six weeks my treatment was stopped but my depression did not lessen.A few days after treatment was stopped, i noticed that the tinnitus that i had in my left ear since 2008 was much louder and higher in frequency than before.I also developed hyperacusis and also started noticing tinnitus in my right ear as well.Before my tinnitus was rather mild, but now it was so loud and high pitched that i could hear it over everything.It became difficult to sleep and i even became suicidal.

• Brand Name: NEUROSTAR TMS THERAPY SYSTEM
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION SYSTEM
• Manufacturer (Section D): NEURONETICS
• MDR Report Key: 5335596
• MDR Text Key: 34702492
• Report Number: MW5058804
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B12
• Patient Age: 50 YR
• Patient Weight: 77