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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Fibrosis (3167); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Patient was seen in clinic and presented with high lead impedance.It was noted that the magnet was swiped but there was no response and the patient had x-rays performed.The x-ray images were received and reviewed by the manufacturer.The generator placement was determined to be in the upper left chest.Based on the images provided, the feedthrough wires were intact, however could not be assessed if pin was completely inserted due to the angle of the image.A portion of the lead was visualized in the chest and neck.The strain relief bend and loop are present however the strain relief was not placed per labeling.There could only be one tie down visualized due to the quality of the image however was not placed per labeling.A portion of the lead was visualized to be behind the generator.The lead was assessed for fracture and discontinuities on the visible portions of the lead however none were noted.Based on the x-rays received, the cause of the high impedance cannot be determined; however, any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out.No known 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.

Event Description

Additional information received noting that the patient underwent a full revision.The surgeon found many adhesions on the vagus nerve which prevented the passage of current from the electrode to the nerve.The new electrode was positioned above the adhesion.The explanted devices were discarded.

• 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: 14462840
• MDR Text Key: 292381301
• Report Number: 1644487-2022-00583
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2020
• Device Model Number: 304-20
• Device Lot Number: 4738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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 Age: 8 YR
• Patient Sex: Male