MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

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

Patient Problem Nerve Damage (1979)

Event Date 11/02/2016

Event Type  Injury  

Event Description

It was reported that the patient¿s left vagus nerve was damaged.The patient¿s treating ent physician stated that it appeared to occur during a surgery, but it was not clear if vns surgery or a prior brain surgery was responsible.It was believed the site of the damage was slightly higher than the level of the vns leads, specifically referencing damage at the palate region of the nerve.The ent physician reportedly performed a laryngoscopy and showed the patient had reduced sensation of the larynx, and muscle activations were delayed and less forceful.A modified variance swallow study was performed, and the tongue muscles and general pharyngeal muscles were found to not perform as well as they should.The physician¿s assessment of the issue was that since the left vagus nerve innervates the left palate, and the patient¿s left pallet did not elevate, the results signified damage to that vagus nerve.However, patient¿s vocal cords were reported to be normal.Knowing that left palate is innervated higher up on the vagus nerve, the damage was assessed by the physician to possibly have happened prior to vns.The patient was confirmed to have multiple other brain surgeries, including brain tumor removal, over the course of his life.However, the patient's vns surgery could not be ruled out as a contributing factor.

• Brand Name: LEAD MODEL 303
• 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: 6252761
• MDR Text Key: 64885482
• Report Number: 1644487-2017-03030
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2018
• Device Model Number: 303-20
• Device Lot Number: 4039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• 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): Disability
• Patient Age: 48 YR