MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 7304

Model Number 7304-20

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

Patient Problems Inflammation (1932); Paralysis (1997); Irritability (2421)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Clinical study patient was experiencing right vocal cord paralysis (lead implant site for vitaria).Vocal cord paralysis noted to be possibly related to stimulation, implant and other.No additional relevant information has been received.

Event Description

Patient was reported to be experiencing laryngitis and having throat irritation with stimulation.Patient started having voice alteration and hoarseness with up titration.Patient status post placement of a vagus nerve stimulator which resulted in a paralyzed right vocal cord.No additional relevant information has been received.

Event Description

The laryngitis is resolving.The vocal cord paralysis has no resolved to date.No corrective action is required as no new cause or new harm has been established for patient or user.

• Brand Name: LEAD MODEL 7304
• 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: 13081733
• MDR Text Key: 284705061
• Report Number: 1644487-2021-01836
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

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: 10/17/2022
• Device Model Number: 7304-20
• Device Lot Number: 5956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/01/2022; 03/04/2022
• Supplement Dates FDA Received: 01/27/2022; 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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: 72 YR
• Patient Sex: Male