ALPHA-STIM TECHNOLOGY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-19 for ALPHA-STIM TECHNOLOGY manufactured by Epi, Inc.

Event Text Entries

[4120513] Pt called to report adverse reaction to alpha-stim electrode. He stated he used this device as treatment for a phobia of flying. He tried it on (b)(6) 2013, and said he followed the directions and tried the device at the minimum current for the minimum amount of time, which is 20 minutes. Since he used the device, he has been experiencing severe tinnitus. He stated it's been 6 months and he still has the tinnitus and he doesn't know what to do. He stated it's ruining his life. He said he's tried acupuncture, and visited an ent doctor to help his condition, but nothing is helping and the doctor didn't find any problems. He said he feels the company lied to him and that tinnitus was not listed as a possible side effect when using the device. He mentioned that he is considering contacting a lawyer because he doesn't know what else to do. He also stated he read info on the internet, that it has been reported to the fda that people have experienced tinnitus using this device. He is very upset this is not listed as a possible side effect.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5033542
• MDR Report Key: 3532948
• Date Received: 2013-12-19
• Date of Report: 2013-12-19
• Date of Event: 2013-06-23
• Date Added to Maude: 2013-12-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• 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: ALPHA-STIM TECHNOLOGY
• Generic Name: ELECTRODE
• Product Code: JXK
• Date Received: 2013-12-19
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EPI, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-19