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

Model Number 304-30

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

Patient Problems Unspecified Infection (1930); Swelling (2091); Fluid Discharge (2686); No Code Available (3191)

Event Date 01/04/2016

Event Type  Injury  

Event Description

It was reported on that a patient had been experiencing swelling at her generator site and drainage at her neck incision site for about 1 year.The neurologist sent the patient to the emergency room in response.It was later reported that the patient was admitted to the er after presenting with an acute fistula between the neck incision site and generator site and swelling at the generator site.The patient was discharging a serous fluid from her neck.The device could not be explanted, so the patient was prescribed an antibiotic for one week and discharged from the hospital.Device history records were reviewed and confirmed that both of the devices were sterilized prior to release.No additional relevant information has been received to date.No known surgical intervention has been taken to date.

Event Description

It was reported that a patient's lead and generator were explanted due to infection, per the patient's surgeon.No additional information has been provided 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: 6283113
• MDR Text Key: 65949122
• Report Number: 1644487-2017-03084
• 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: 03/24/2017

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: 08/31/2018
• Device Model Number: 304-30
• Device Lot Number: 203085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR