MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Tingling (2171); Complaint, Ill-Defined (2331); Choking (2464)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient reported she was referred to an ear, nose, and throat (ent) doctor by her neurologist for evaluation of persistent hoarseness.The ent diagnosed the patient with vocal cord paresis/paralysis with the believed cause to be intubation during vns implant surgery.The patient reported that she also experiences choking, some coughing and tingling in the back of her throat.She stated that her voice is improving and she may have to undergo surgical repair.Post-implant medical records obtained from the neurologist indicate that surgery was uncomplicated, that the patient experienced a rough voice afterwards but no swallow dysfunction at that time, and that vns stimulation was well tolerated by the patient.On a subsequent visit it was noted that the patient was concerned that her voice had not come back yet.Vns parameters were increased at the visit and noted to be tolerated well by the patient, and the patient was referred to the ent.Medical records obtained from the ent describe persistent hoarseness starting immediately after vns surgery that has not worsened or improved since surgery, some dysphagia while eating & drinking, and occasional cough.Endoscopic evaluation of her larynx demonstrated left true vocal cord paresis/paralysis that appears to be complete.The ent records stated that the patient wished to continue with periodic observation and not pursue any treatment at this time.The patient was asked to return to the ent in 2 months.No known interventions have occurred to date.

• Brand Name: LEAD MODEL 304
• 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: 5105420
• MDR Text Key: 26821858
• Report Number: 1644487-2015-05887
• 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
• Report Date: 09/01/2015

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: 10/21/2018
• Device Model Number: 304-20
• Device Lot Number: 4130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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: 35 YR