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

Model Number 302-20

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

Patient Problems Unspecified Infection (1930); Fibrosis (3167)

Event Date 07/10/2008

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by a surgeon that in the past the patient had a severe infection and had to be explanted.The site of the infection was at the neck and around the vagus nerve.The infection had left scarring that made it impossible to re-implant on the left vagus nerve.The manufacturer's device history records were reviewed and verified sterilization prior to final release.No further relevant information has been received to date.

Manufacturer Narrative

The original report did not indicate that intervention was required.

Event Description

Operative notes were received describing the patient's explant surgery due to her infection.This operation was planned as an exploratory surgery due to exuberant granulation tissue and believed wound breakdown at her neck incision.The generator pocket was palpated, and upon compression, there was visible cloudy fluid extravasating from the cervical wound consistent with a continuous infected fluid pocket.For this reason, both the lead and generator were explanted.The scarring was noted to be extensive during lead explant.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: GENERATOR
• 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: 6566676
• MDR Text Key: 75144505
• Report Number: 1644487-2017-03800
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2011
• Device Model Number: 302-20
• Device Lot Number: 200793
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2008
• 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): Other; Required Intervention
• Patient Age: 11 YR