MAUDE Adverse Event Report: FISHER WALLACE LABORATORIES FISHER WALLACE STIMULATOR

Model Number FW-100

Device Problem Insufficient Information (3190)

Patient Problems Memory Loss/Impairment (1958); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Date 09/12/2016

Event Type  Injury  

Event Description

I started use of a wallace fisher cranial electrical stimulation device saturday, (b)(6) 2016, that was purchased the week before use was at the recommended dose of 20 minutes on setting 2 twice a day.The first 2 nights, i had extremely vivid nightmares that i could not wake up from and was disoriented and unable to focus the remainder of the day.By the 3rd day of use (monday (b)(6)), i was unable to wake up until after 14 hours of sleep and was very disoriented, with difficulty in balance and coordination and a disoriented "drugged" feeling that lasted all day, greatly affecting my ability to concentrate, focus, make decisions and most other general cognitive processes, plus my memory was severely affected - for example my mother took me to a store where i could not remember why we went there or what i was supposed to get.By the 4th day, after 16 hours of sleeping, i required the aid of my mother in order to wake up, again having disorientation, incoordination and the drugged feeling making it impossible for me to completely perform anything that required focus, awareness or memory due to being in such a state of brain fog.In short, in 5 short days i went from being able to think clearly (i'm an animal behaviorist) to being a zone-out, stoner-like zombie.In addition to the above, my major depressive disorder has become much worse, with severe hopelessness, lack of interest in anything (i was found by both my spouse and mother staring blankly at a wall), with severely increased depression, anxiety, impatience and great hostility.My mother purchased this device for me to aid my depression because of the plethora of positive studies listed on the manufacturer's website and as i had been unable to be helped by pharmaceuticals due to so many adverse reactions, some life-threatening.Plus she bought this for me (as i have been unable to work due to my disability) at great hardship to herself as she only receives a small government pension.So to have paid so much for this device only to have my depression become worse is heart-crushing.

• Brand Name: FISHER WALLACE STIMULATOR
• Type of Device: FISHER WALLACE STIMULATOR
• Manufacturer (Section D): FISHER WALLACE LABORATORIES
• MDR Report Key: 5955760
• MDR Text Key: 55121309
• Report Number: MW5064789
• Device Sequence Number: 1
• Product Code: JXK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FW-100
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B SUPREME COMPLEX; CARVEDILOL; CLONAZAPAM; KRILL OIL; MAGNESIUM OXIDE; OTC MEDS: COMPLETE MINERAL COMPLEX; PROGESTERONE; RX MEDS: NEURONTIN; TRAMADOL; VITAMIN C
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 64