MAUDE Adverse Event Report: ENEURA INC. STMS MINI; TRANSCRANIAL MAGNETIC STIMULATOR FOR THE TREATMENT MIGRAINE HEADACHE

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 07/17/2019

Event Type  Injury  

Event Description

The pt who is my wife used a tms mini, a portable single-pulse transcranial magnetic stimulation device for the first time on the morning of (b)(6) 2019.She has significant chronic hemiplegic migraines.The device was prescribed by dr (b)(6) at the (b)(6) clinic in (b)(6).She was feeling well with no symptoms of migraine when she began her treatment with the device.She delivered two "clicks" as directed in the written instructions and as directed by a nurse, (b)(4), from the eneura company.After the first click, my wife had a sensation of something odd happening in her brain.Immediately after the second click, she began to have the usual symptoms that occur with her more severe migraines: significant facial sagging, extreme drooping of her right eyelid, tingling in her right arm and hand, anxiety, confusion.Additionally she reported a sensation that something was "wrong" in her brain.Within 10 mins, she was having a full blown migraine along with an unusual pressure sensation around the top of her head.It was unusual for her to feel pressure around her whole head instead of only on the right side.Her cognitive function worsened.She had extreme drooping of her right eye.When she tried to stand up, she was very unsteady and required assistance to walk from a chair to her bed.She described the event as the worst migraine she has had with the add'l symptom of the pressure in her upper head.Within a few hours, the pressure sensation stopped but the migraine persisted.Today is (b)(6) 2019 4 days later and she is still having symptoms of the migraine.The symptoms have lessened somewhat but her activities and ability to function normally are still impaired.She has contacted both dr (b)(6)'s office and (b)(4), the nurse from eneura about the problem.Dr (b)(6)'s office nurse said that she should not use the device again.Ms (b)(6) suggested that she should use the device again with only one click and then gradually increase the frequency.When asked about data to support continued use.Ms (b)(6) did not provide any on first request, but later recounted one anecdotal case.Ms (b)(6) in her third email, responding to questions from my wife about whether or not people who have reactions like hers are followed and if any permanent harm has been reported, reported the following on (b)(6) 2019: "studies show that this device does not cause migraines.If you get a migraine after using the device, you would have gotten the migraine anyway.That is the answer i always get when i ask for pts who have an adverse reaction.That being said, i don't find the answer helpful for pts.Some people's brains do not do well with the extra stimulation.Most who have this reaction, stop using it for fear of further downward spiral, so to say we have data on pts who have had this reaction and then do well is hard to honestly tell you." we believe that the pulse delivered by the machine caused the occurrence of this severe neurologic reaction.The timing, the severity, the difference in symptoms, onset, and progression from her normal migraines all point to the fact that the treatment caused the neurologic changes.The pt manual does state that treatment can cause migraine.Neither dr (b)(6) or ms (b)(6) pointed this out in advance of treatment.Fda safety report id# (b)(4).

• Brand Name: STMS MINI
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR FOR THE TREATMENT MIGRAINE HEADACHE
• Manufacturer (Section D): ENEURA INC. ; sunnyvale CA 94085
• MDR Report Key: 8821857
• MDR Text Key: 152160285
• Report Number: MW5088306
• Device Sequence Number: 1
• Product Code: OKP
• UDI-Device Identifier: 00816140020088
• UDI-Public: 00816140020088
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 68