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 Ecchymosis (1818); Edema (1820); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

It was reported that the patient had a hematoma in his neck post-implant and is on antibiotics.Significant swelling in the neck was present.The physician insinuated that the cause of the hematoma and swelling was due to surgical error and not due to the vns lead.It was also noted that per the doctor, the lead was not tunneled deep enough and therefore it is protruding under the skin.It was noted that this has caused a point of irritation and a potential for erosion, and even the patient's clothes make the raised skin appear red.The device history records were reviewed for the generator and lead.The devices passed all functional and quality testing prior to distribution.The devices were confirmed to have been hp sterilized.No other relevant information has been received to date.

Event Description

It was noted that the physician did not provide antibiotics for the hematoma and swelling and there was no further intervention as he believed that the issue would resolve over time.An x-ray was requested for the lead protrusion and surgical revision was considered.X-rays have not been reviewed by the manufacturer to date.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient had surgery to repair the system by changing the location of a tie-down and adding strain relief.The system remains functional.No other relevant information has been received to date.

Event Description

It was reported that the lead issue and associated pain has resolved but the patient is still very sensitive to stimulation.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 10837046
• MDR Text Key: 216152418
• Report Number: 1644487-2020-01521
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2024
• Device Model Number: 304-20
• Device Lot Number: 205181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2020
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male