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 Apnea (1720); Hypoxia (1918)

Event Date 10/25/2017

Event Type  Injury  

Event Description

It was reported that patient was experiencing sleep apnea with stimulation.Patient had a sleep study performed and experienced many respiratory events with mild to moderate oxygen desaturation in relation to vns stimulation.Device was programmed off and there was a complete resolution of apneas and hypneus.Apneas was found to be obstructive in nature and reported to be severe.Vns stimulation was linked to the sustained collapse of the tongue base, epiglottis, supraglottis, and glottis.Vns activation caused supraglottic contraction with complete obstruction of vocal cords.Vns activation cause sustained laryngospasm.No additional relevant information has been received.

Manufacturer Narrative

F10.Health effect - clinical code - correction - code e0726 was not included in initial mdr.

Event Description

Patient had a generator replacement.The explanted generator has not been received to date.

Event Description

Generator was received and product analysis is underway.

Event Description

Generator analysis was performed.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified.Device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Comprehensive automated electrical evaluation showed that the device performed according to functional specifications.Review of the data dump revealed no anomalies.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 12731773
• MDR Text Key: 279409863
• Report Number: 1644487-2021-01516
• 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,Followup
• Report Date: 03/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2018
• Device Model Number: 106
• Device Lot Number: 5056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/02/2021; 01/07/2022; 02/08/2022
• Supplement Dates FDA Received: 11/23/2021; 02/01/2022; 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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): Life Threatening; Required Intervention; Other
• Patient Age: 10 YR
• Patient Sex: Male