MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 10/03/2016

Event Type  Injury  

Event Description

It was reported that the patient's vns was planned to be explanted due to an abscess in the neck.The patient was reportedly admitted to the hospital in relation to this symptom.The surgery has not been reported to have occurred to date.Attempts for additional pertinent information have been unsuccessful to date.

Event Description

Information was received from the treating surgeon.The date of the infection was stated as (b)(6) 2016.The surgeon noted swelling at the left chest pocket and the left and anterior lateral neck near the vns incision and a tracheostomy site.The surgeon expressed the infection did not appear to be related to vns placement.The patient had an infection at their tracheostomy site that spread to the area of the vns.Potential contributing factors were secretions from the tracheostomy or mouth and poor hygiene.Both the lead and generator were explanted on (b)(6) 2016 in relation to the infection.At the time of the explant procedure, large amounts of purulence, necrotic tissue, inflamed tissue and scarring were noted at the lead and generator sites.Following explant and irrigation, drain tubes were installed at the site of the infection.No additional pertinent information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 6052713
• MDR Text Key: 58243716
• Report Number: 1644487-2016-02454
• 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
• Report Date: 10/04/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: 302-20
• Device Lot Number: 200431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2007
• 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; Required Intervention
• Patient Age: 16 YR