MAUDE Adverse Event Report: PREMIER PSYCHIATRIC OMAHA TMS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tinnitus (2103); Anxiety (2328); Distress (2329); Depression (2361)

Event Date 10/12/2015

Event Type  Injury  

Event Description

I had a initial tms treatment through (b)(6).I was not warned how serious the side effects could be.When the treatment started i had severe pain in my temple on the right side so the technician moved the device and lowered the frequency.It was 20 minutes of pure hell.I have ptsd and every time that tapping started i felt like i was going to jump out of my of my skin.For 36 hours i didn't know what the heck was happening to me.I literally kept "perservating" about getting in my car and driving off a bridge.I couldn't focus on anything sane.Last night i finally started to feel better.I think i slept off and on but never for more than a couple hours at a time.I have no idea if i took proper care of my dog.I may or may not have fed him more than usual.I just hope future patients are warned and maybe someone should be with them for 24 hours in case something happens.I have severe depression so i dont' socialize or have any one i could call to come and stay with me.The ringing in my ears that i have had for years is twice as loud and that is very bothersome also.The technician told me that problem with tinnitus is often cured.Not for me.It's much worse.

• Brand Name: TMS
• Type of Device: TMS
• Manufacturer (Section D): PREMIER PSYCHIATRIC OMAHA
• MDR Report Key: 5161892
• MDR Text Key: 28811881
• Report Number: MW5057226
• Device Sequence Number: 1
• Product Code: NDP
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Weight: 69