MAUDE Adverse Event Report: LIVANOVA USA, INC. VAGUS NERVE STIMULATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Model Number 1000 GENERATOR 304 LEAD

Device Problem Output Problem (3005)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Suicidal Ideation (4429)

Event Date 03/04/2021

Event Type  Injury  

Event Description

I had a vagus nerve stimulator implanted for depression.The stimulator is manufactured by livanova.The stimulator was turned on two weeks after surgery and i have been in severe pain ever since.The left side of my neck hurts continually, i have severe headaches almost daily and generally do not feel well.I had the stimulator turned off in the middle of (b)(6) 2021 but the pain, headaches and not feeling well has not gone away.My psychiatrist and the surgeon have no idea what the problem is.I have reached out to several other doctors to see if they could help me but they have no training in this area and we're of no help.I had a complete physical to rule out another cause of not feeling well and nothing was found.I was reluctant to have the stimulator removed because i desperately need relief from my depression and anxiety because medications are not working well.I finally reached out to the manufacturer livanova in (b)(6) 2021 to see if they had any ideas as to what was causing the problems.At first they said they have never had a patient with the problem i am having.My husband researched the fda web site and found a lot of cases similar to mine.After informing my livanova contact about what we found from the fda they said they would research their database.They supposedly have been researching since september 2021.I am in contact with them almost weekly and all i get is empty promises.I have decided to have the stimulator removed but my surgeon hasn't called me back.Since the implant my depression and anxiety has gotten considerably worse.I contemplate suicide regularly and would have done so not long ago if i had not been found.Devices like this should not be allowed to be implanted in people if when a problem arises, no one knows what to do.I believe a third party should have reviewed the data.I have also had an mri, ct scan, and x-rays all reviewed by livanova employees.Fda safety report id# (b)(4).

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 12712117
• MDR Text Key: 278807151
• Report Number: MW5105009
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 10/26/2021

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
• Device Model Number: 1000 GENERATOR 304 LEAD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BUSPIRONE HCL 60 MG DAILY; CHROMIUM PICOLINATE; DIAZEPAM 5MG DAILY; DULOXETINE 60 MG DAILY; ESOMPRAZOLE 40 MG DAILY; FAMOTIDINE 40 MG DAILY; GAPAPENTIN 500 TO 600 MG DAILY; KEDAMINE 100MGLML 10 SPRAYS DAILY; L-METHYFOLATE; L-THYROXINE 150 MCDONALD'S DAILY; MAGNESIUM; METHYLPHENIDATE 60 MG DAILY; SUPER B COMPLEX; TRAZADONE 300 MG DAILY; VITAMIN D3
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 59