MAUDE Adverse Event Report: CYBERONICS/ LIVANOVA USA, INC. VNS THERAPY PATIENTS ESSENTIALS; STIMULATOR, AUTOMATIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 220

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Choking (2464)

Event Date 03/15/2018

Event Type  Injury  

Event Description

My daughter recently had a cyberonics vns device model 220 implanted.Although it's not listed as a "known" side effect - my daughter and another child with a vns i know both now require water thickener (not sure if permanent for my child - other child has needed fluids thickened for three years now).This device leaves children with the complication of children choking on fluids if not thickened after device is installed.

• Brand Name: VNS THERAPY PATIENTS ESSENTIALS
• Type of Device: STIMULATOR, AUTOMATIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS/ LIVANOVA USA, INC.
• MDR Report Key: 7435789
• MDR Text Key: 105797526
• Report Number: MW5076513
• 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: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 220
• Device Lot Number: 2140516
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 13 YR
• Patient Weight: 43