MAUDE Adverse Event Report: ENEURA, INC. STMS MINI; TRANSCRANIAL MAGNETIC STIMULATOR

Model Number DWG-0500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Headache (1880); Tingling (2171); Anxiety (2328); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 07/17/2019

Event Type  Injury  

Event Description

It was reported that the patient began treatment of her chronic hemiplegic migraines with the stms mini on (b)(6) 2019 and delivered two "clicks" as directed in the written instructions and as prescribed by her doctor.Prior to using the stms mini, the patient was feeling well with no symptoms of migraine.After the first click, the patient 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 arma nd hand, anxiety, confusion.Additionally she reported a sensation that something was "wrong" in her brain.Within 10 minutes, 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 additional symptom of the pressure in her upper head.Within a few hours, the pressure lessened somewhat but her activities and ability to function normally are still impaired.She contacted the doctor's office and the nurse from eneura about the problem.

• Brand Name: STMS MINI
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): ENEURA, INC.; 715 n. pastoria ave; sunnyvale CA 94085
• Manufacturer (Section G): ENEURA, INC.; 715 n. pastoria ave; sunnyvale CA 94085
• Manufacturer Contact: cynthia merrell ; 715 n. pastoria ave; sunnyvale, CA 94085
• MDR Report Key: 8879917
• MDR Text Key: 153878016
• Report Number: 3008487930-2019-00001
• Device Sequence Number: 1
• Product Code: OKP
• Combination Product (y/n): N
• PMA/PMN Number: K161663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWG-0500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other