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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Seizures (2063)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The patient underwent full explant on (b)(6) 2015.Per the surgeon, the scar tissue and remaining length of the nerve were such that re-implantation could not be completed.The patient is currently seizure free with her current medication regimen so at this point the patient is going to continue with clinical management and not pursue right sided vns placement at this time.The explanted devices are not available for return therefore product analysis will not be completed.

Event Description

The patient¿s mother reported on (b)(6) 2015 that the patient has had poor seizure control lately, and that she was hospitalized over the prior few days.She was admitted to the hospital.At that time, the vns was checked and x-rays were taken.The mother reported that she was told that there may have been an issue with the patient¿s vns leads.Additional information was later received that diagnostics confirmed high impedance on (b)(6) 2015, and the device was subsequently turned off.The patient's mother said seizures increased once "medicines started being adjusted." the surgeon reported that the x-ray appears to show a kinking-issue with the lead.It was reported that there appears to be a slight fracture above the superficial strain relief loop near the sternocleidomastoid muscle.The surgeon suspected that the lead may have gotten kinked and subsequently fractured.No known surgical intervention has occurred to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

Event Description

On (b)(6) 2016 it was reported that the patient under went a full right-sided nerve placement and left chest placement of the vagal nerve stimulator.

• 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: 4767189
• MDR Text Key: 5809564
• Report Number: 1644487-2015-04681
• 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,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2015; 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2011
• 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