MAUDE Adverse Event Report: PULSETTO PULSETTO VAGUS NERVE STIMULATION DEVICE SKU: PULSETTODEVICE; STIMULATOR, MUSCLE, POWERED

Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Fatigue (1849); Palpitations (2467); Unspecified Heart Problem (4454)
Date of Event	10/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I used the pulsetto machine on sunday morning (b)(6) pulsetto is designed to give a strong stimulus to the vagus nerve to aid in relaxation.Unfortuntately, the vagus nerve is a neuromodulator of the heart.After i used it that morning, i felt some palpitations which i tried to ignore.After church i went to a spinning class, and i had to stop several times due to fatigue and i noticed i had an irregular heartbeat.Later that day i went to well now urgent care on (b)(6) and was diagnosed with frequent ventricular arrhythmias.My thyroid and other blood tests are normal.I do not have any history of heart disease and am in excellent shape.Later that week i saw my pcp who ordered a 3-day heart monitor and that showed that7.4% of my heart beats were ventricular instead of atrial.I still suffer from very frequent palpitations and exercise fatigue.I asked pulsetto is this is a known side effect, and they said people with heart disease shouldn't use pulsetto but i don't have known heart disease.I feel this product should be taken off the market for the possibly permanent harm it has done me and the potential harm it could do other people.I am scheduled to see a cardiologist next week.I continue to have constant palpitations and exercise fatigue.

• Brand Name: PULSETTO VAGUS NERVE STIMULATION DEVICE SKU: PULSETTODEVICE
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): PULSETTO; 470 old worthington rd; ste 200; westerville OH 43082
• MDR Report Key: 23497093
• Report Number: MW5178610
• Device Sequence Number: 14753857
• Product Code: IPF
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESCITALOPRAM 20 MG QD.; OMEPRAZOLE 20 MG QD.; TADALAFIL 2.5 MG QD,.; VITAMIN B12 1 QD.; VITAMIN D 5000 UNITS Q WEEK.
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White