MAUDE Adverse Event Report: CYBERONICS VAGUS NERVE STIMULATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Headache (1880); Twitching (2172)

Event Date 10/03/2013

Event Type  Injury  

Event Description

Vagus nerve stimulator generator was replaced and re-implanted on (b)(6) 2013.That evening he experienced his first uncontrolled head movement.It appears to jerk forward and down then back very quickly.We saw this happen on (b)(6).There were probably other dates it happened, but these are the ones that were witnessed.On (b)(6) he had a 24 hr eeg during which he had several of these movements.On each date these movements happened multiple times and was causing great discomfort to our son.Each time this happened he was left tired and would say his head hurt.Our son is mentally disabled and is not able to fully explain his experience.On 3 occasions he was holding an ipad, or iphone and we thought it was related to that, but following episodes he was not holding anything.The vns settings were set in surgery.Since the surgery, he has had to endure a 24 hour eeg to rule these out as seizures.It was determined that they are not seizures therefore we believe they are indeed the device causing this.The neurologist has adjusted the vns twice and after the second time we haven't seen any yet.

Event Description

Additional info received on 2/26/2014: our son was riding in the car watching a movie and his head jerked downward and back up three times.This happened very quickly and lasted just a few seconds.He is tired and holds his head after.He had these start happening immediately following the replacement of the vns generator on (b)(6) 2013.There were several other episodes but i did not log them all down.The vns settings were adjusted by his neurologist and we didn't see any events for several days.Then on (b)(6) 2014 we saw it happen again while riding in the car.These events were reported to his neurologist dr.(b)(6) and she called cyberonics on three occasions.They have not responded to our issue with this generator.I happened to see two of cyberonics sales rep at an informal epilepsy meeting in (b)(6), and i did tell them about it, and they stated they knew dr.(b)(6) had called and that they were supposed to call us but had not at that time.It had been a week and we received no call.About a week or two later we were in dr.(b)(6)'s office and she asked if anyone had called us and we told her no.She made one or two other phone calls to cyberonics and explained what was happening and they have failed to follow up with us on this problem.We have just seen this one episode since the last vns adjustment, but we feel they may just be happening less often and nor always visualized.

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: VAGUS NERVE STIMULATOR
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 3599446
• MDR Text Key: 4093679
• Report Number: MW5034038
• Device Sequence Number: 1
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 103
• Device Lot Number: 907110
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 53