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 Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816)

Event Date 12/03/2019

Event Type  Injury  

Event Description

It was reported by the company representative that the neurologist had turned the patient's device off due to complaints of voice irritation and shortness of breath.The physician and patient agreed to schedule generator replacement for newer technology but also referred her for lead revision to ensure that the lead placement was sufficient.Clinic notes confirmed that the vns was disabled due to hoarseness and swallowing difficulties and chest pain.The patient's lead and generator were replaced.While performing the lead revision, the surgeon saw that the lead veered off from where he thought the lead should normally be placed.He believed it was possible that the lead was implanted on the wrong nerve and this was causing the patient's symptoms; although upon follow-up he indicated it could be possible that it was just placed on a different part of the vagus nerve.The surgeon reported that the revision had resolved the patient's concerns per the mother.When asked whether the surgery was for patient comfort or to preclude a serious injury, the physician indicated that it was for newer technology (note that the lead did not need to be replaced for newer technology.) no further relevant information has been received to date.Product return is not expected per the hospital protocol.

Event Description

It was reported per the surgeon that the patient's surgery was not to preclude a serious injury.No further relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9527458
• MDR Text Key: 179415668
• Report Number: 1644487-2019-02522
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: 04/01/2018
• Device Model Number: 304-20
• Device Lot Number: 3896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Required Intervention
• Patient Age: 39 YR