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

Model Number 304-20

Device Problem Low impedance (2285)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

Report received that low impedance was observed on a patient's vns.A manufacturer representative followed up with the patient about a month later and ran system diagnostic tests.Low impedance was still seen.The patient reportedly denied having any recent injuries or trauma that could have damaged the lead.The physician increased the patient's settings where she reportedly felt a noticeable difference.She also had voice alteration at the higher settings.This indicated some stimulation was still being delivered to the vagus nerve despite the low impedance.A review of the device history record indicated the lead had passed all quality inspections prior to being release for distribution.No surgical intervention has occurred and no further relevant information has been received to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently did not check adverse event.(b)(4).

Event Description

Further information was received from the patient's physician that there was no indication of any trauma or manipulation that might have occurred which could have led to low impedance.When the patient was seen on the day low impedance was first seen, the patient reportedly had discomfort in her throat with stimulation.The patient was reportedly seen at a later date.The system diagnostic test run on this day showed an impedance value within normal limits.There was no data available in the programming history for review and no additional data has been reviewed to date.No further relevant information has been received to date and no surgical intervention has occurred.

Event Description

Additional information received noting that the patient underwent full revision surgery.The explanted products have not been received by product analysis 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: 7138842
• MDR Text Key: 95542166
• Report Number: 1644487-2017-05063
• 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
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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): Other
• Patient Age: 20 YR
• Patient Sex: Female