MAUDE Adverse Event Report: NEUROMD MEDICAL TECHNOLOGIES NEUROMD; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number	NONE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I have been having problems with the neuromd device.Multiple times i felt a strong burn/shock sensation.Plus, the device stimulation tappers off before it should.I have spoken three times to their customer service reps.First time they admitted there was a bad part in the device and sent me a new one.Received that and now the same thing is happening again rep only tells me it's because the gel pad isn't stuck on my back will enough.To try another pad.The pads are (b)(6) for 3 of them, i can't throw away a pad after 3 uses.They say the pads last for 20 or so uses.The rep isn't helpful.I feel like a guinea pig.I highly doubt they are keeping a complaint file.The burn/ shock really hurts.Please check them out.This burn/shock has happened about 4 times now.It is the second time a part has failed.They deny it is failing.Fda safety report id # (b)(4).

• Brand Name: NEUROMD
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): NEUROMD MEDICAL TECHNOLOGIES; 18201 collins ave 4309a ; sunny isles beach, FL 33160
• MDR Report Key: 11541707
• Report Number: MW5100155
• Device Sequence Number: 15385482
• Product Code: GZJ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/18/2021
• 2 Devices were Involved in the Event: 1 2

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
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR