MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Dysphagia/ Odynophagia (1815); Aspiration Pneumonitis (4455)

Event Date 07/06/2022

Event Type  Injury  

Event Description

It was reported that patient was experiencing dysphagia.Provider is not sure how long he has had that setting but believes it causing/contributing to dysphagia.The device was disabled.It was further reported that patient had improvement with dysphagia after disablement.Patient has been admitted to hospital for dysphagia and aspiration pneumonia.Vns was interrogated and within normal limits.Physician reports that patient's settings appear to be quite high and are likely contributing to his dysphagia.Physician and aspiration pneumonia are believed to secondary effects of vns.No additional relevant information has been received to date.

Event Description

It was reported that magnet stimulation is on and the battery is low and needs to be replaced.The cause of the dysphagia was marked as being due to other and not due to stimulation, low battery and external factors.The pneumonia was reported to be related to external factors and not due to stimulation, low battery and external factors.The only intervention that will be taken is a battery change.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent a battery replacement and the explanted generator was discarded.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15262417
• MDR Text Key: 298280408
• Report Number: 1644487-2022-01025
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2018
• Device Model Number: 106
• Device Lot Number: 4905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Sex: Female