MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Date 05/01/2015

Event Type  Injury  

Event Description

Information was received indicating that the patient was experiencing vocal cord paralysis which began on the date of vns surgery, (b)(6) 2015.The patient followed up with an ear, nose and throat physician who recommended surgery to address the vocal cord paralysis and the patient is reportedly considering this option.No known surgical interventions have occurred to date.The patient¿s treating neurologist reported that vns stimulation was turned on (b)(6) 2015 and is being titrated upward.The neurologist indicated there are no problems with the patient's vns system other than the patient being hoarse.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received indicating that the patient returned to the ear, nose, and throat physician and indicated she would like to move forward with the procedure, a left vocal cord injection procedure.It was reported that the patient was experiencing some gastro-intestinal issues at the time which required evaluation by a gastroenterologist before the left vocal cord injection procedure could be performed.No known procedures have occurred to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4928776
• MDR Text Key: 6032801
• Report Number: 1644487-2015-05241
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 303-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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): Other
• Patient Age: 53 YR