FISHER WALLACE BRAIN STIMULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-16 for FISHER WALLACE BRAIN STIMULATOR manufactured by Fisher Wallace.

Event Text Entries

[5520403] A psychiatrist recommended the fisher wallace stimulator for my husband's depression. My husband had been previously treated successfully for 24 years with antidepressants. He started using the stimulator at the end of (b)(6) 2014. He was told by the psychiatrist that he would be able to be weaned off his antidepressant. Once he was totally off the antidepressants and solely using the stimulator, he experienced extreme irritability and anxiety. The week before christmas, he started experiencing extreme depression and severe tiredness. On (b)(6) 2014, he took his own life. I feel that the reason that he took his life is due to the fisher wallace stimulator and the false claims of how well it works for depression. Each person has different types of depression caused by many different reasons. I do not believe that this stimulator is safe and effective on just any person diagnosed with depression. I also believe that patients need to be closely supervised while using this product. My husband, sadly, was not.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040804
• MDR Report Key: 4538850
• Date Received: 2015-02-16
• Date of Report: 2015-02-16
• Date of Event: 2014-12-27
• Date Added to Maude: 2015-02-25
• 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 FAMILY MEMBER OR FRIEND
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FISHER WALLACE BRAIN STIMULATOR
• Generic Name: FISHER WALLACE BRAIN STIMULATOR
• Product Code: JXK
• Date Received: 2015-02-16
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FISHER WALLACE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2015-02-16