MAUDE Adverse Event Report: CYBERONICS / LIVANOVA USA, INC. VAGUS NERVE STIMULATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 101 NCP

Device Problems Corroded (1131); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Scar Tissue (2060)

Event Date 04/02/2018

Event Type  Injury  

Event Description

My disabled son had his vagus nerve stimulator queried at a routine neurology visit in (b)(6) 2018.This showed a lead malfunction.A chest x-ray showed a partial lead detachment.On (b)(6) 2018 surgery was done to replace the vns at (b)(6) in (b)(6).Surgery showed the leads had corroded and one was not attached.The neurosurgeon had to leave part of the leads in that are wrapped around the vagus nerve due to scar tissue.He was not able to remove the scar tissue to fully remove the old leads.Original leads were placed (b)(6) 2000 with the first surgery at (b)(6) in (b)(6) (dr (b)(6)).Cyberonics rep for (b)(6) is aware and was present for the surgery.We do not know why the leads corroded and the long term risks for them being left in wrapped around his vagus nerve.Dr (b)(6), np neuro surgeon: dr (b)(6).Vns generator has been replaced several times as expected for the battery.Fda safety report id# (b)(4).

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 8821792
• MDR Text Key: 152160674
• Report Number: MW5088303
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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
• Report Date: 07/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 101 NCP
• Device Lot Number: LEAD 300 NCP
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 91