STIMULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-26 for STIMULATOR manufactured by .

Event Text Entries

[15356142] I used the fisher wallace stimulator as a treatment for depression, chronic pain, anxiety and insomnia. My first treatment was (b)(6) 2014. Immediately after the treatment ended, i developed a severe headache in my temples and across my forehead that has not diminished as of (b)(6) 2014. The documentation included with this device warned of a possible mild headache in the area of the conductor pads during the treatment, but the headache would end when the treatment ended and this mild headache was rare. I have returned of any kind. I followed the instructions of the documentation to the letter and watched the video demo on the fisher wallace website as well. I had every expectation that i would have no serious side effects. I have not contacted fisher wallace to report the problem as i am not aware they have a trained medical practitioner available for consultation. I have no idea how long this headache may last and i have no recourse other that a refund for the purchase price.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5038867
• MDR Report Key: 4217183
• Date Received: 2014-10-26
• Date of Report: 2014-10-26
• Date of Event: 2014-10-22
• Date Added to Maude: 2014-11-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STIMULATOR
• Generic Name: STIMULATOR
• Product Code: JXK
• Date Received: 2014-10-26
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-10-26