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

Model Number 304-20

Device Problem Low impedance (2285)

Patient Problems Convulsion, Clonic (2222); No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

It was reported that the patient was seen in clinic and system diagnostics was performed twice with results showing low impedance.The patient indicated that they have always felt stimulation until a few months ago when they could no longer feel it.No additional relevant information has been received to date.

Event Description

Additional information was received that patient needs a revision due to low lead impedance; however, before surgery the physician wants to confirm that the patient is having epileptic seizures.Per patient history, after being implanted with vns and titrated up several times, the patient stopped having seizures.The patient reported to the physician that they were still having seizures, just not as many.The sales representative was asked to check the patient's device as the magnet was not stopping seizures like it used to and could no longer feel stimulation.During the discussion of the patient's physician history, it was uncovered that the patient was sent for an eeg in 2017 in which no epileptic seizures were recorded.Based on this, the physician now would like to confirm epileptic seizures before deciding to proceed with a surgery.No known surgery has occurred to date.

Event Description

It was reported by the physician that the patient's seizures are suspected to be non epileptic.Further diagnostics testing indicated that the impedance of the device is now within normal limits.No surgical intervention has occurred to date.No additional or 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: 11280992
• MDR Text Key: 230449184
• Report Number: 1644487-2021-00158
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2017
• Device Model Number: 304-20
• Device Lot Number: 3779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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: 45 YR
• Patient Sex: Female