MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 06/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received indicating that a vns patient had been experiencing a persistent sore throat since the time of stimulation.The provider indicated that the patient's sore throat is experienced all the time but more so during vns stimulation.The patient's neurologist stated that device function was normal with normal diagnostics and vns stimulation had been turned on following the patient's surgery.A vocal cord video strobe performed by the patient's ear, nose, and throat physician revealed that the left true vocal cord is in the paramedical position and vibrates on phonation without adduction or abduction; the right true vocal cord works well.The assessment was that the patient was experiencing dysphonia and dysphagia secondary to vns implant.It was reported that normal lead impedances have been observed since implant with the latest measured lead impedance being 1,928 ohms (date of measurement unknown).No known further interventions have occurred to date.

• 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: 5238140
• MDR Text Key: 31674547
• Report Number: 1644487-2015-06462
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2018
• Device Model Number: 303-20
• Device Lot Number: 4065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 33 YR