MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problem Swollen Lymph Nodes (2093)

Event Date 02/09/2015

Event Type  Injury  

Event Description

It was reported that the patient's lymph node was swollen at the site of the electrode.The physician started the patient on prophylactic antibiotics in case the swelling was indicative of an infection.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

The physician reported that the cause for the swollen lymph nodes was due to infection, but it is not known what the cause for the infection was.Planned intervention was to refer the patient to the physician and provide antibiotics.

Manufacturer Narrative

This information was inadvertently left off of initial mfr.Report.

Event Description

The patient experienced dull pain and swelling at the electrode site on (b)(6) 2015 after the pulse width was increased soon after the infection occurred.The physician believed that this was an expected event because of the infection.The incision was reported to be well healed.There was no reported intervention for the infection after the antibiotics.

• Brand Name: PULSE GEN MODEL 103
• 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: 4592599
• MDR Text Key: 5481701
• Report Number: 1644487-2015-04126
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 3832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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): Required Intervention
• Patient Age: 43 YR