MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Scar Tissue (2060); Post Traumatic Wound Infection (2447)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient developed a postoperative anterior cervical wound infection (stitch abscess) following vns implant surgery which occurred on (b)(6) 2015.On (b)(6) 2015 the patient's physician treated the infection via drainage and antibiotics and cultures were taken.A second stitch abscess involving the superior aspect of the cervical incision was observed on (b)(6) 2015 and drained on that date.On (b)(6) 2015 purulent fluid was noted at the pocket and cervical wound site with associated extrusion of one of the lead tie-downs.On that date pulse generator and partial lead removal was then undertaken and was initially deemed to have been successful at resolving the infection, however the infection recurred again at a later date.Due to the recurring infection the physician elected to remove all remaining portions of the lead on (b)(6) 2015.During the subsequent removal procedure the anchor tether and negative electrode were observed to be detached from the vagus nerve and this observation was attributed to the prior partial lead removal procedure.Scar tissue was observed in the nerve area.Patient drooling is believed to have contributed to the infection and it stated that the patient is very susceptible to infections.Manufacturing records were reviewed for the patient's pulse generator and lead and proper sterilization was confirmed prior to device shipment.The explanted devices were discarded by the explanting facility.

• 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: 5431179
• MDR Text Key: 38047012
• Report Number: 1644487-2016-00220
• 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: 01/14/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2019
• Device Model Number: 304-20
• Device Lot Number: 4222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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: 3 YR