MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Chest Pain (1776); Seizures (2063)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

It was reported that the patient¿s vns system registered high lead impedance (>10,000 ohms) in an office visit.This occurred approximately 2 months after initial implant.The patient reportedly had no significant injury leading up to the high impedance.The patient complained of pain around the generator site when the device stimulated.The high impedance appeared to be intermittent, as high impedance was detected when the patient was sitting, but was within normal limits when the patient was standing or leaned back.The pain also reportedly depended on position.A company representative reviewed the x-rays on-site, but could not visualize the lead to be inserted past the connecting block.The generator and lead device history records were reviewed and found that all specifications were met prior to distribution.X-ray images of the patient¿s vns were received and reviewed by the manufacturer.The generator was placed normally per labeling.Due to the angle of the image, the lead pin could not be assessed to be visualized past the connector blocks.The feedthru wires appeared to be intact.The lead electrodes appeared to be appropriately placed per labeling.No gross lead discontinuities or sharp angles were observed.A small portion of the lead was obscured by the generator.Surgery to address the high impedance has not occurred to date.No additional pertinent information has been received to date.

Event Description

Clinic notes from the patient's recent surgical consult reported that the patient believed her device was not working as she had not experienced an improvement in the frequency of her seizures.It is unclear if this began with the high impedance.The surgical consult notes also indicated that the patient was still experiencing positional discomfort.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

The patient's neurologist confirmed that the patient believed that the vns was not improving her seizure frequency around the same time that the high impedance was identified.No additional relevant information has been received to date.No surgical intervention has occurred to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6286574
• MDR Text Key: 66059251
• Report Number: 1644487-2017-03105
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2020
• Device Model Number: 304-20
• Device Lot Number: 4909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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): Required Intervention
• Patient Age: 59 YR