MAUDE Adverse Event Report: VAGAL NERVE STIMULATOR ; STIMULATOR, AUTONOMIC NERVE, IMPLANED FOR EPILEPSY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Dizziness (2194); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 11/17/2019

Event Type  Injury  

Event Description

My son is currently taking 5ml of epidiolex/twice a day and i'm noticing he is starting to vomit on more than one occasion.The fifth time being on (b)(6) 2019.He started epidiolex on (b)(6) 2019 at the lowest dosage of 1ml and on (b)(6) he vomited excessively (3) separate times.Since then, the vomiting has happened 4 others times, with the recent event on (b)(6) 2019.I'm concerned now, because he has not had these issues in the past.His eyes are not yellowing, his labs continue to come back fine, with the recent labs being done on (b)(6) 2019 and i have not gotten results back from those.I called my son's neurologist dr (b)(6), this a.M., and spoke with his nurse about my concerns.My son told me last evening that he is confused, and he feels dizzy.He will get up and then just kind of stands and looks at me, as though he is about to say something, but doesn't.I ask him what is it and he states, i don't know; this is not him.My son is (b)(6) and very bright.His appetite is also diminished-foods that he really likes, he now has very little appetite for much.He recently ((b)(6) 2019) had a new and lasted vns device implanted.I don't know if this is the problem, but he definitely has not been himself.Between the epidiolex and the vns, something is definitely not right.Look forward to hearing from you.Regards, (b)(6).I have not been notified of the results as of (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: VAGAL NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANED FOR EPILEPSY
• MDR Report Key: 9354220
• MDR Text Key: 167630624
• Report Number: MW5091223
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 78