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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Event Description

An article titled ¿the role of laryngeal electromyography in vagus nerve stimulation-related vocal fold dysmotility"¿ was published in 2016.All participants in the study had been implanted with a vns device for 2-5 years and reported experiencing mild to severe hoarseness.During the study the patient's throat muscles were evaluated during stimulation off times and on times using electromyography and endoscopy.The article reported that during the study it was determined that 2 of the patients were suffering from vocal cord palsy.No additional relevant information has been received to date.Manufacturer report # 1644487-2016-02880 captures patient #1 who had experienced vocal cord paresis with and without vns stimulation.This report captures patient #2 who had experienced vocal cord paresis without vns stimulation however experienced forced adduction during vns stimulation.It was noted that during vns stimulation off times the patient's muscles exhibited tonic spastic activity during breathing with reduced phasic modulation during phonation.These symptoms were not modified during vns stimulation on times.When vns stimulation was occurring the patient was experiencing forced adduction.Following the forced adduction the patient experienced muscle spasms in the thyroarytenoid and cricothyroid muscles for about 5 seconds following vns stimulation.

• 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: 6182583
• MDR Text Key: 62679976
• Report Number: 1644487-2016-02881
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR