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

Model Number 1000

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

Patient Problem Aspiration/Inhalation (1725)

Event Date 12/12/2019

Event Type  Injury  

Event Description

My daughter had a sentiva generator device classified #1 most deadly and serious during the surgery.While intubated she aspirated and was injected with hydromorphone and vancomyacin.She still has injected material with the head of a needle by her neck.

• Brand Name: SENTIVA GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 16086061
• MDR Text Key: 306608267
• Report Number: MW5114106
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Lot Number: 204895
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLEGRAA; B12; BRIVIACT NEBULIZER MACHINE ; CARBAMEPAZINE ; GABEPENTIN; KEPPRA; TROKENDI ; VITAMIN D3 ; WHEELCHAIRBOUND; XANEX,DICYCLOMINE; XOPONEX AS WELL AS THE INHALER
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White