MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Unspecified Infection (1930); Swelling (2091)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015 it was reported that the patient has a neck incision complaint and that the patient is seeing the surgeon on (b)(6) 2015.The physician¿s office reported that the ¿neck incision complaint¿ was an infection at the neck site; there was some bruising or hematoma and slight swelling and discoloration.The nurse said that it was from the vns surgery.They decided to wait to turn the vns on since the patient was having the infection.They did not do cultures; they just prescribed the patient antibiotics.They are not going to do any other interventions besides the antibiotics.They saw the patient again recently on (b)(6) 2015 and she was much better, the bruising had gone down, and they decided to turn the vns on.The manufacturing records for both the lead and generator were reviewed and it was confirmed that the devices were sterilized prior to shipment.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5206821
• MDR Text Key: 30574009
• Report Number: 1644487-2015-06355
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2019
• Device Model Number: 304-20
• Device Lot Number: 4220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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