MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Dyspnea (1816); Convulsion, Clonic (2222); Aspiration Pneumonitis (4455)

Event Date 05/30/2021

Event Type  Injury  

Event Description

The patient's mother reported that the patient has pneumonia and is having increased seizures.She thought that the vns may not be working.Information was received from the neurologist that the patient is in the icu with pneumonia and a possible upper airway obstruction.The patient is having daily seizures, and the neuro believes this is related to the pneumonia.The patient's device was found to be working and settings were decreased.The neuro wants to rule out if the upper airway obstruction is related to vns.The airway obstruction is thought to be separate from the pneumonia as it started a couple of months ago, however the airway obstruction did seem to worsen with the pneumonia.No further relevant information has been received to date.

Event Description

The pneumonia was confirmed to unrelated to vns per the physician.The upper airway issue resolved when output current was decreased, so this seems to have been related to stimulation.As the increased seizures were related to the pneumonia, it can also be concluded that the seizures were unrelated to vns.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12359871
• MDR Text Key: 267876449
• Report Number: 1644487-2021-01184
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2021
• Device Model Number: 1000
• Device Lot Number: 205138
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 16 YR