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

Model Number 304-20

Device Problem Extrusion (2934)

Patient Problem Inflammation (1932)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had inflammation and lead extrusion at the neck incision about six weeks after implant surgery.There was no indication of an infection.The physician did not know the cause of the inflammation or lead extrusion since the wound had been healing well after the implant surgery.On (b)(6) 2015, the lead was reinserted into the neck without the nerve and electrodes being touched during the procedure, and the incision was closed.The incision was reported to be healing well after the surgery.

Event Description

It was reported that an infection was present at the generator and lead sites on (b)(6) 2015.Infected skin necrosis on the left chest wall was found, and an open wound was visible with drainage.The generator and lead were explanted on (b)(6) 2015.The infection appeared spontaneously and was not attributed to patient manipulation.The physician plans to re-implant the patient with a new vns system in 3 months, because the patient responded well to therapy.The device history records for the generator and lead were reviewed, and both were sterilized prior to distribution.Attempts for additional information were unsuccessful to date.

Event Description

The physician believed that the cause of the infection was that the patient developed a seroma at the generator site 4 weeks post-op.Cultures were taken, and the result was staphylococcus aureus with multiple sensitivities (not (b)(6)).

• 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: 5224608
• MDR Text Key: 31196397
• Report Number: 1644487-2015-06409
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2018
• Device Model Number: 304-20
• Device Lot Number: 203152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: 3 YR