MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Paresis (1998); Dysphasia (2195); Choking (2464)

Event Date 09/30/2015

Event Type  Injury  

Event Description

It was reported via clinic notes that patient had vns implanted on (b)(6) 2015 and has since been having complaints of hoarseness and choking.The surgeon did a scope and said the vocal cord was abnormal.The patient was reportedly drinking and eating some, but not all foods due to the dysphagia.Additional information was received that the left vocal cord was only partially paralyzed (paresis), and is improving.Both the paresis and dysphagia are thought to be due to both the implant surgery and vns stimulation.The patient is continually being monitored for these issues, and they are reportedly improving.No additional relevant information has been received 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: 5270442
• MDR Text Key: 32772898
• Report Number: 1644487-2015-06657
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/12/2015

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: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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: 26 YR