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

Model Number 304-20

Device Problems High impedance (1291); Inappropriate or Unexpected Reset (2959)

Patient Problem Convulsion, Clonic (2222)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

It was reported that patient has been in the hospital and will be needing neck surgery due to experiencing a fall from their seizures.The device was interrogated and it was observed that the device was not programmed on.A surgery report of the patient's recent replacement was also provided which notes the replacement generator was programmed on and the surgery was successful with no issues.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Manufacturer Narrative

Section d.Suspect medical device; corrected information; initial mdr listed incorrect suspect device h4.Device manufacture date; corrected information; initial mdr listed incorrect date.

Event Description

Information was received from the physician reporting that they suspect the vns is not working and that the surgeon implanted the device wrong.The physician notes that the device was interrogated and the vns is not recording anything.Due to the no stimulation, the patient experienced a seizure and fall which required hospitalization and now has a tracheostomy device.The vns was interrogated and confirmed that the device was on at one point, but was unable to identify why the device was not stimulating.Additional information was received from the physician who suspects that the lead may have not been properly inserted.X-rays were ordered and the patient was referred for surgery.No other 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: 16664743
• MDR Text Key: 312556811
• Report Number: 1644487-2023-00404
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2020
• Device Model Number: 304-20
• Device Lot Number: 300392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male