MAUDE Adverse Event Report: PULSETTO PULSETTO; STIMULATOR, MUSCLE, POWERED

Medical Device Problem Codes	Crack (1135); Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Using pulsetto vagus nerve stimulator heavily marketed on facebook and social media and game ads.First device flimsy and housing cracked open and exposed wiring and returned for replacement.On (b)(6) 2025, i was using replacement device and started charging it.The indicator light stopped flashing and i picked up device and burned my hand and noted the housing was melting.This device is poorly constructed and a fire and injury hazard and this company needs to be held accountable for placing people at risk and making all the claims they make and push in their ads.There are no serial numbers that i can see and on insistence of manufacturer i have sent the second defective device back to the company.Pt code: 2685.Device codes: 1135, 1437, 1385.Ref report: mw5178703.

• Brand Name: PULSETTO
• Common Device Name: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): PULSETTO; 470 old worthington rd; ste 200; westerville OH 43082
• MDR Report Key: 23543403
• Report Number: MW5178818
• Device Sequence Number: 12365346
• Product Code: IPF
• Combination Product (Y/N): N
• 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): 11/05/2025

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPAP(CONTINUOUS POSITIVE AIRWAY PRESSURE); LISINOPRIL; METOPROLOL SUCCINATE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Race: White