MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

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

Patient Problems Bradycardia (1751); Paralysis (1997); Complaint, Ill-Defined (2331)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that this patient was admitted to (b)(6) that day (transferred from (b)(6)) who had a vns implanted in (b)(6) and upon awakening had hoarseness and cough and since then an ent told him he had a paralyzed vocal cord.His vns was turned on a few days later.His vns was interrogated upon his arrival.The normal and magnet mode were then programmed off.It is unknown what the cause of the vocal cord issues are.A voluntary medwatch mw5065529 was submitted for the vocal cord issues and bradycardia.Bradycardia was reported in medwatch report # 1644487-2016-02512.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: 6096929
• MDR Text Key: 59765620
• Report Number: 1644487-2016-02624
• 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: 10/19/2016

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: Lay User/Patient
• Device Expiration Date: 07/29/2019
• Device Model Number: 304-20
• Device Lot Number: 203460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• 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: 37 YR