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

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

Patient Problem Convulsion/Seizure (4406)

Event Date 01/02/2021

Event Type  Injury  

Event Description

Had seizure and hospitalized for 3 weeks still not being helped or treated for vns problems i am a veteran and this is who had vns implanted 1st time by u.S.Department of veterans affairs.Need help seizures have increased pain in neck chest not being treated.Fda safety report id # (b)(4).

• Brand Name: VNS
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 11561940
• MDR Text Key: 242389725
• Report Number: MW5100214
• 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
• Type of Report: Initial
• Report Date: 03/21/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 61 YR
• Patient Weight: 104