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 Problem Pain (1994)

Event Date 05/30/2014

Event Type  Injury  

Event Description

It was reported that ever since initial implant, the patient experienced constant ear pain that was worse during stimulation.In the past, the physician tried reducing the settings but the pain did not resolve.The patient suspected the pain was related to the placement of the lead wire and desired a full revision surgery.The surgeon opted only to replace the generator, stating the cause of the pain in the ear could not be confirmed.It was recommended that the patient see the original surgeon who implanted the lead.It was also noted that the patient has allergies and recently was in a car accident, which may be related to the ear pain.Attempts for additional info have been made; no additional relevant info has been received to date.No further surgical intervention has occurred to date.

Event Description

Information was received indicating that the patient had been seen by an ent, who assessed that the lead may have been initially implanted too high on the vagus nerve, or that the electrode coils were not appropriately sized for the patient.The ent also recommended a lead repositioning surgery.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient underwent lead revision surgery due to the reported ear pain.During the surgery, it was identified that there was inadequate strain relief on the lead and the strain relief was in the wrong location.The surgeon also noted that the electrodes were too high on the nerve, and the electrode diameter was too narrow for the patient's vagus nerve.The lead was replaced and was confirmed to have a better fit around the nerve.The explanted lead has not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

Patient had full replacement due to jaw and ear pain.At first it was mostly during stimulation he said, but then it became constant.Immediately after the operation, the patient said he felt no more ear pain or jaw pain.

• 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: 11095624
• MDR Text Key: 224382605
• Report Number: 1644487-2020-01752
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2022

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: 12/05/2017
• Device Model Number: 304-20
• Device Lot Number: 3815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 03/10/2021; 05/26/2022
• Supplement Dates FDA Received: 01/22/2021; 04/02/2021; 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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: 32 YR
• Patient Sex: Male