MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

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

Patient Problems Aspiration/Inhalation (1725); Paralysis (1997)

Event Date 04/28/2021

Event Type  Injury  

Event Description

A patient was diagnosed with vocal cord paralysis and was reported to be aspirating.The patient has been referred to an ent and speech therapist.No other relevant information has been received to date.

Event Description

Additional information received indicating that the vocal cord paralysis and aspiration were related to the implant procedure.The vocal cord paralysis has since stopped and resolved.The patient underwent diagnostic exams/test for both events.

Manufacturer Narrative

Lot expiration date, corrected data: initial report inadvertently listed ni.Manufacture date, corrected data: initial report inadvertently listed ni.

Event Description

The aspiration has since stopped and the outcome was noted to be recovered/resolved.

Event Description

Additional information received noting that the reported vocal cord paralysis is definitely related to the implant procedure, stimulation and the device.

Event Description

Additional information received noting that the reported vocal cord paralysis is not related to stimulation.

Event Description

Additional information received noting that the reported vocal cord paralysis is definitely related to stimulation.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 11952134
• MDR Text Key: 254817952
• Report Number: 1644487-2021-00775
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/24/2023

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: 03/09/2022
• Device Model Number: 304-20
• Device Lot Number: 205379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/08/2021; 07/22/2021; 04/20/2022; 09/07/2022; 03/30/2023
• Supplement Dates FDA Received: 06/30/2021; 08/19/2021; 05/13/2022; 09/30/2022; 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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): Disability
• Patient Age: 58 YR
• Patient Sex: Female