inforMED
InjuryIPF

PULSETTO FIT VAGUS NERVE STIMULATOR

Received Jun 1, 2026

Report MW5188819 · MDR key 25351110

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Pulsetto

Patient

NA · Male

  • Headache
  • Anxiety
  • Distress
  • Neck Pain
  • Sleep Dysfunction
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

REPORTER SAYS THAT HE WAS PLAYING VIDEO GAMES WHEN HE SAW AN AD FOR A DEVICE CLAIMING TO CURE INSOMNIA, PAIN, AND ANXIETY, AND TO MAKE PEOPLE CALM. HE PURCHASED IT AND DOWNLOADED THE ACCOMPANYING APP TO CONTROL IT. THE DEVICE HAS DIFFERENT MODES, INCLUDING AN INSOMNIA MODE FOR BEFORE BED, A HEADACHE MODE, A PAIN MODE, AND AN ANXIETY MODE THAT PLAYS MEDITATIVE MUSIC. HOWEVER, ALL THE DEVICE ACTUALLY DOES IS CREATE A TINGLING SENSATION ON THE NECK. INSTEAD OF HELPING, IT MADE HIS SYMPTOMS WORSE; THE SENSATION WAS IRRITATING AND PAINFUL, LEAVING HIM MORE STRESSED OUT AND ANXIOUS, AND HIS INSOMNIA HAS WORSENED. THERE IS NO EASY WAY TO CONTACT TECH SUPPORT, AND WHEN HE DID REACH THEM, THEY MERELY TOLD HIM TO KEEP TRYING IT. ADDITIONALLY, HE NOTICED A MONTHLY FEE ASSOCIATED WITH THE APP. ONLINE RESEARCH SHOWS THAT PEOPLE HAVE DEBUNKED THE DEVICE, REVEALING THAT ALL THE DIFFERENT MODES ARE TOTAL NONSENSE. THE PATIENT BELIEVES THIS IS FALSE ADVERTISING FOR A BAD DEVICE THAT DOES NOTHING BENEFICIAL. HE SUSPECTS HIS SYMPTOMS HAVE WORSENED, PARTICULARLY HIS CHRONIC NECK PAIN, POSSIBLY DUE TO THE ELECTRODES. FINALLY, WHILE THE ADVERTISEMENT CLAIMS THE PRODUCT IS "CLINICALLY FOUND" TO WORK, THE WEBSITE PROVIDES ABSOLUTELY NO CLINICAL PROOF TO BACK UP THIS CLAIM.