sTMS mini DWG-0501-UKRecalls & reported problems
Eneura, Inc., · Transcranial Magnetic Stimulator Device · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816140020088), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Unexpected Therapeutic Results1
Patient problems
- Ambulation or Postural Difficulties1
- Anxiety1
- Headache1
- Neurological Deficit/Dysfunction1
- No Code Available1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2019Unexpected Therapeutic Results
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. W
Patient problems: Ambulation or Postural Difficulties; Anxiety; Headache; Neurological Deficit/Dysfunction; No Code Available; Therapeutic Effects, Unexpected
MAUDE report 8821857 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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